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Antibiotics versus topical antiseptics for chronic suppurative otitis media.
Head, K, Chong, LY, Bhutta, MF, Morris, PS, Vijayasekaran, S, Burton, MJ, Schilder, AG, Brennan-Jones, CG
The Cochrane database of systematic reviews. 2020;(1):CD013056
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Abstract
BACKGROUND Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and infection of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Antibiotics and antiseptics kill or inhibit the micro-organisms that may be responsible for the infection. Antibiotics can be applied topically or administered systemically via the oral or injection route. Antiseptics are always directly applied to the ear (topically). OBJECTIVES To assess the effectiveness of antibiotics versus antiseptics for people with chronic suppurative otitis media (CSOM). SEARCH METHODS The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL; 2019, Issue 4, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019. SELECTION CRITERIA We included randomised controlled trials (RCTs) with at least a one-week follow-up involving patients (adults and children) who had chronic ear discharge of unknown cause or CSOM, where ear discharge had continued for more than two weeks. The intervention was any single, or combination of, antibiotic agent, whether applied topically (without steroids) or systemically. The comparison was any single, or combination of, topical antiseptic agent, applied as ear drops, powders or irrigations, or as part of an aural toileting procedure. Two comparisons were topical antiseptics compared to: a) topical antibiotics or b) systemic antibiotics. Within each comparison we separated where both groups of patients had received topical antibiotic a) alone or with aural toilet and b) on top of background treatment (such as systemic antibiotics). DATA COLLECTION AND ANALYSIS We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks, and after four weeks; health-related quality of life using a validated instrument; and ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways. MAIN RESULTS We identified seven studies (935 participants) across four comparisons with antibiotics compared against acetic acid, aluminium acetate, boric acid and povidone-iodine. None of the included studies reported the outcomes of quality of life or serious complications. A. Topical antiseptic (acetic acid) versus topical antibiotics (quinolones or aminoglycosides) It is very uncertain if there is a difference in resolution of ear discharge with acetic acid compared with aminoglycosides at one to two weeks (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.72 to 1.08; 1 study; 100 participants; very low-certainty evidence). No study reported results for ear discharge after four weeks. It was very uncertain if there was more ear pain, discomfort or local irritation with acetic acid or topical antibiotics due to the low numbers of participants reporting events (RR 0.16, 95% CI 0.02 to 1.34; 2 RCTs; 189 participants; very low-certainty evidence). No differences between groups were reported narratively for hearing (quinolones) or suspected ototoxicity (aminoglycosides) (very low-certainty evidence). B. Topical antiseptic (aluminium acetate) versus topical antibiotics No results for the one study comparing topical antibiotics with aluminium acetate could be used in the review. C. Topical antiseptic (boric acid) versus topical antibiotics (quinolones) One study reported more participants with resolution of ear discharge when using topical antibiotics (quinolones) compared with boric acid ear drops at between one to two weeks (risk ratio (RR) 1.56, 95% confidence interval (CI) 1.27 to 1.92; 1 study; 409 participants; moderate-certainty evidence). This means that one additional person will have resolution of ear discharge for every five people receiving topical antibiotics (compared with boric acid) at two weeks. No study reported results for ear discharge after four weeks. There was a bigger improvement in hearing in the topical antibiotic group compared to the topical antiseptic group (mean difference (MD) 2.79 decibels (dB), 95% CI 0.48 to 5.10; 1 study; 390 participants; low-certainty evidence) but this difference may not be clinically significant. There may be more ear pain, discomfort or irritation with boric acid compared with quinolones (RR 0.56, 95% CI 0.32 to 0.98; 2 studies; 510 participants; low-certainty evidence). Suspected ototoxicity was not reported. D. Topical antiseptic (povidone-iodine) versus topical antibiotics (quinolones) It is uncertain if there is a difference between quinolones and povidone-iodine with respect to resolution of ear discharge at one to two weeks (RR 1.02, 95% CI 0.82 to 1.26; 1 RCT, 39 participants; very low-certainty evidence). The study reported qualitatively that there were no differences between the groups for hearing and no patients developed ototoxic effects (very low-certainty evidence). No results for resolution of ear discharge beyond four weeks, or ear pain, discomfort or irritation, were reported. E. Topical antiseptic (acetic acid) + aural toileting versus topical + systemic antibiotics (quinolones) One study reported that participants receiving topical and oral antibiotics had less resolution of ear discharge compared with acetic acid ear drops and aural toileting (suction clearance every two days) at one month (RR 0.69, 95% CI 0.53 to 0.90; 100 participants). The study did not report results for resolution of ear discharge at between one to two weeks, ear pain, discomfort or irritation, hearing or suspected ototoxicity. AUTHORS' CONCLUSIONS Treatment of CSOM with topical antibiotics (quinolones) probably results in an increase in resolution of ear discharge compared with boric acid at up to two weeks. There was limited evidence for the efficacy of other topical antibiotics or topical antiseptics and so we are unable to draw conclusions. Adverse events were not well reported.
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Nasal decontamination for the prevention of surgical site infection in Staphylococcus aureus carriers.
Liu, Z, Norman, G, Iheozor-Ejiofor, Z, Wong, JK, Crosbie, EJ, Wilson, P
The Cochrane database of systematic reviews. 2017;(5):CD012462
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Abstract
BACKGROUND Surgical site infection rates in the month following surgery vary from 1% to 5%. Due to the large number of surgical procedures conducted annually, the costs of these surgical site infections (SSIs) can be considerable in financial and social terms. Nasal decontamination using antibiotics or antiseptics is performed to reduce the risk of SSIs by preventing organisms from the nasal cavity being transferred to the skin where a surgical incision will be made. Staphylococcus aureus (S aureus) colonises the nasal cavity and skin of carriers and can cause infection in open or unhealed surgical wounds. S aureus is the leading nosocomial (hospital-acquired) pathogen in hospitals worldwide. The potential effectiveness of nasal decontamination of S aureus is thought to be dependent on both the antibiotic/antiseptic used and the dose of application; however, it is unclear whether nasal decontamination actually reduces postoperative wound infection in S aureus carriers. OBJECTIVES To assess the effects of nasal decontamination on preventing surgical site infections (SSIs) in people who are S aureus carriers undergoing surgery. SEARCH METHODS In September 2016 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus. We also searched three clinical trial registries and the references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting. SELECTION CRITERIA Randomised controlled trials (RCTs) which enrolled S aureus carriers with any type of surgery and assessed the use of nasal decontamination with antiseptic/antibiotic properties were included in the review. DATA COLLECTION AND ANALYSIS Two review authors independently performed study selection, data extraction, risk of bias assessment and GRADE assessment. MAIN RESULTS We located two studies (291 participants) for inclusion in this review. The trials were clinically heterogeneous with differences in duration of follow-up, and nasal decontamination regimens. One study compared mupirocin (2% contained in a base of polyethylene glycol 400 and polyethylene glycol 3350) with a placebo in elective cardiac surgery patients; and one study compared Anerdian (iodine 0.45% to 0.57% (W/V), chlorhexidine acetate 0.09% to 0.11% (W/V)) with no treatment also in cardiac surgery patients. The trials reported limited outcome data on SSI, adverse events and secondary outcomes (e.g. S aureus SSI, mortality). Mupirocin compared with placeboThis study found no clear difference in SSI risk following use of mupirocin compared with placebo (1 trial, 257 participants); risk ratio (RR) 1.60, 95% confidence interval (CI) 0.79 to 3.25 based on 18/130 events in the mupirocin group and 11/127 in the control group; low-certainty evidence (downgraded twice due to imprecision). Anerdian compared with no treatmentIt is uncertain whether there is a difference in SSI risk following treatment with Anerdian compared with no treatment (1 trial, 34 participants); RR 0.89, 95% CI 0.06 to 13.08 based on 1/18 events in the Anerdian group and 1/16 in the control group; very low certainty evidence (downgraded twice due to imprecision and once due to risk of bias). AUTHORS' CONCLUSIONS There is currently limited rigorous RCT evidence available regarding the clinical effectiveness of nasal decontamination in the prevention of SSI. This limitation is specific to the focused question our review addresses, looking at nasal decontamination as a single intervention in participants undergoing surgery who are known S aureus carriers. We were only able to identify two studies that met the inclusion criteria for this review and one of these was very small and poorly reported. The potential benefits and harms of using decontamination for the prevention of SSI in this group of people remain uncertain.
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Antibiotics and antiseptics for surgical wounds healing by secondary intention.
Norman, G, Dumville, JC, Mohapatra, DP, Owens, GL, Crosbie, EJ
The Cochrane database of systematic reviews. 2016;(3):CD011712
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Abstract
BACKGROUND Following surgery, incisions are usually closed by fixing the edges together with sutures (stitches), staples, adhesives (glue) or clips. This process helps the cut edges heal together and is called 'healing by primary intention'. However, a minority of surgical wounds are not closed in this way. Where the risk of infection is high or there has been significant loss of tissue, wounds may be left open to heal by the growth of new tissue rather than by primary closure; this is known as 'healing by secondary intention'. There is a risk of infection in open wounds, which may impact on wound healing, and antiseptic or antibiotic treatments may be used with the aim of preventing or treating such infections. This review is one of a suite of Cochrane reviews investigating the evidence on antiseptics and antibiotics in different types of wounds. It aims to present current evidence related to the use of antiseptics and antibiotics for surgical wounds healing by secondary intention (SWHSI). OBJECTIVES To assess the effects of systemic and topical antibiotics, and topical antiseptics for the treatment of surgical wounds healing by secondary intention. SEARCH METHODS In November 2015 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We also searched three clinical trials registries and the references of included studies and relevant systematic reviews. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA Randomised controlled trials which enrolled adults with a surgical wound healing by secondary intention and assessed treatment with an antiseptic or antibiotic treatment. Studies enrolling people with skin graft donor sites were not included, neither were studies of wounds with a non-surgical origin which had subsequently undergone sharp or surgical debridement or other surgical treatments or wounds within the oral or aural cavities. DATA COLLECTION AND ANALYSIS Two review authors independently performed study selection, risk of bias assessment and data extraction. MAIN RESULTS Eleven studies with a total of 886 participants were included in the review. These evaluated a range of comparisons in a range of surgical wounds healing by secondary intention. In general studies were small and some did not present data or analyses that could be easily interpreted or related to clinical outcomes. These factors reduced the quality of the evidence.Two comparisons compared different iodine preparations with no antiseptic treatment and found no clear evidence of effects for these treatments. The outcome data available were limited and what evidence there was low quality.One study compared a zinc oxide mesh dressing with a plain mesh dressing. There was no clear evidence of a difference in time to wound healing between groups. There was some evidence of a difference in measures used to assess wound infection (wound with foul smell and number of participants prescribed antibiotics) which favoured the zinc oxide group. This was low quality evidence.One study reported that sucralfate cream increased the likelihood of healing open wounds following haemorrhoidectomy compared to a petrolatum cream (RR: 1.50, 95% CI 1.13 to 1.99) over a three week period. This evidence was graded as being of moderate quality. The study also reported lower wound pain scores in the sucralfate group.There was a reduction in time to healing of open wounds following haemorrhoidectomy when treated with Triclosan post-operatively compared with a standard sodium hypochlorite solution (mean difference -1.70 days, 95% CI -3.41 to 0.01). This was classed as low quality evidence.There was moderate quality evidence that more open wounds resulting from excision of pyomyositis abscesses healed when treated with a honey-soaked gauze compared with a EUSOL-soaked gauze over three weeks' follow-up (RR: 1.58, 95% CI 1.03 to 2.42). There was also some evidence of a reduction in the mean length of hospital stay in the honey group. Evidence was taken from one small study that only had 43 participants.There was moderate quality evidence that more Dermacym®-treated post-operative foot wounds in people with diabetes healed compared to those treated with iodine (RR 0.61, 95% CI 0.40 to 0.93). Again estimates came from one small study with 40 participants. AUTHORS' CONCLUSIONS There is no robust evidence on the relative effectiveness of any antiseptic/antibiotic/anti-bacterial preparation evaluated to date for use on SWHSI. Where some evidence for possible treatment effects was reported, it stemmed from single studies with small participant numbers and was classed as moderate or low quality evidence. This means it is likely or very likely that further research will have an important impact on our confidence in the estimate of effect, and may change this estimate.
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Preoperative skin antiseptics for preventing surgical wound infections after clean surgery.
Dumville, JC, McFarlane, E, Edwards, P, Lipp, A, Holmes, A, Liu, Z
The Cochrane database of systematic reviews. 2015;(4):CD003949
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BACKGROUND Surgical site infection rates in the month following clean surgery vary from 0.6% (knee prosthesis) to 5% (limb amputation). Due to the large number of clean surgical procedures conducted annually the costs of these surgical site infections (SSIs) can be considerable in financial and social terms. Preoperative skin antisepsis using antiseptics is performed to reduce the risk of SSIs by removing soil and transient organisms from the skin where a surgical incision will be made. Antiseptics are thought to be toxic to bacteria and therefore aid their mechanical removal. The effectiveness of preoperative skin preparation is thought to be dependent on both the antiseptic used and the method of application, however, it is unclear whether preoperative skin antisepsis actually reduces postoperative wound infection, and, if so, which antiseptic is most effective. OBJECTIVES To determine whether preoperative skin antisepsis immediately prior to surgical incision for clean surgery prevents SSI and to determine the comparative effectiveness of alternative antiseptics. SEARCH METHODS For this third update we searched just the Cochrane Wounds Group Specialised Register (searched 27 January 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 12). SELECTION CRITERIA Randomised controlled trials evaluating the use of preoperative skin antiseptics applied immediately prior to incision in clean surgery. There was no restriction on the inclusion of reports based on language of publication, date or publication status. DATA COLLECTION AND ANALYSIS Data extraction and assessment of risk of bias were undertaken independently by two review authors. MAIN RESULTS There were no new studies added to the review in the third updateThirteen studies were included in this review (2,623 participants). These evaluated several different types of skin antiseptics - leading to 11 different comparisons being made. Although the antiseptics evaluated differed between studies, all trials involved some form of iodine. Iodine in alcohol was compared to alcohol alone in one trial; one trial compared povidone iodine paint (solution type not reported) with soap and alcohol. Six studies compared different types of iodine-containing products with each other and five compared iodine-containing products with chlorhexidine-containing products.There was evidence from one study suggesting that preoperative skin preparation with 0.5% chlorhexidine in methylated spirits led to a reduced risk of SSI compared with an alcohol based povidone iodine solution: RR 0.47 (95% CI 0.27 to 0.82). However, it is important to note that the trial does not report important details regarding the interventions (such as the concentration of povidone iodine paint used) and trial conduct, such that risk of bias was unclear.There were no other statistically significant differences in SSI rates in the other comparisons of skin antisepsis. Overall the risk of bias in included studies was unclear.A mixed treatment comparison meta-analysis was conducted and this suggested that alcohol-containing products had the highest probability of being effective - however, again the quality of this evidence was low. AUTHORS' CONCLUSIONS A comprehensive review of current evidence found some evidence that preoperative skin preparation with 0.5% chlorhexidine in methylated spirits was associated with lower rates of SSIs following clean surgery than alcohol-based povidone iodine paint. However this single study was poorly reported. Practitioners may therefore elect to consider other characteristics such as costs and potential side effects when choosing between alternatives.The design of future trials should be driven by the questions of high priority to decision makers. It may be that investment in at least one large trial (in terms of participants) is warranted in order to add definitive and hopefully conclusive data to the current evidence base. Ideally any future trial would evaluate the iodine-containing and chlorhexidine-containing solutions relevant to current practice as well as the type of solution used (alcohol vs. aqueous).
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Comparison of triclosan and stannous fluoride dentifrices on parameters of gingival inflammation and plaque scores: a systematic review and meta-analysis.
Sälzer, S, Slot, DE, Dörfer, CE, Van der Weijden, GA
International journal of dental hygiene. 2015;(1):1-17
Abstract
OBJECTIVE To systematically review the literature to compare the efficacy of triclosan (Tcs) and stannous fluoride (SnF) dentifrices on parameters of gingivitis and plaque scores. MATERIALS AND METHODS Medline, EMBASE and Cochrane Central Register of Controlled Trials were searched up to March 2013 to identify appropriate studies. Studies regarding self-performed manual brushing by adults with a minimum 4 weeks of follow-up were included. Primary outcomes were parameters of gingivitis. Secondary outcome was plaque score. RESULTS Of 55 publications, 11 met the eligibility criteria. Additionally, four unpublished papers were added after contacting the manufacturers of the leading brands. In total, 15 studies [10 medium term and five long term (>6 months)] were processed for data analysis. There was no difference in gingival index (or its modification) between the two types of dentifrice [DiffM-0.04, 95% confidence interval CI (-0.11; 0.04); P = 0.34]. The change in the average gingival bleeding score was significantly in favour of SnF [DiffM0.02, 95% CI (0.01; 0.02); P < 0.00001]. Plaque scores demonstrated a statistical significant difference in favour of Tcs, according to Quigley-Hein Plaque Index (Q&H PI; DiffM-0.29, 95% CI [-0.45; -0.13]; P = 0.0004), but there was no difference according to Rustogi Modified Navy Plaque Index (RMNPI) [DiffM-0.09, 95% CI (-0.01; 0.18); P = 0.07]. Long-term results supported these findings. CONCLUSIONS In the context of inconclusive results for the primary outcome variable of gingival health, it can be concluded that there was a minor and most likely clinically insignificant difference between Tcs- and SnF-containing dentifrices. Meta-analysis of plaque score reduction was also inconclusive; whereas Tcs was more effective when assessed by the Q&H PI, it was not when scored with the RMNPI.
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Antibiotics and antiseptics for venous leg ulcers.
O'Meara, S, Al-Kurdi, D, Ologun, Y, Ovington, LG, Martyn-St James, M, Richardson, R
The Cochrane database of systematic reviews. 2014;(1):CD003557
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BACKGROUND Venous leg ulcers are a type of chronic wound affecting up to 1% of adults in developed countries at some point during their lives. Many of these wounds are colonised by bacteria or show signs of clinical infection. The presence of infection may delay ulcer healing. Two main strategies are used to prevent and treat clinical infection in venous leg ulcers: systemic antibiotics and topical antibiotics or antiseptics. OBJECTIVES The objective of this review was to determine the effects of systemic antibiotics and topical antibiotics and antiseptics on the healing of venous ulcers. SEARCH METHODS In May 2013, for this second update, we searched the Cochrane Wounds Group Specialised Register (searched 24 May 2013); the Cochrane Central Register of Controlled Trials (CENTRAL 2013, Issue 4); Ovid MEDLINE (1948 to Week 3 May 2013); Ovid MEDLINE (In-Process & Other Non-indexed Citations, 22 May 2013); Ovid EMBASE (1980 to Week 20 2013); and EBSCO CINAHL (1982 to 17 May 2013). No language or publication date restrictions were applied. SELECTION CRITERIA Randomised controlled trials (RCTs) recruiting people with venous leg ulceration, evaluating at least one systemic antibiotic, topical antibiotic or topical antiseptic that reported an objective assessment of wound healing (e.g. time to complete healing, frequency of complete healing, change in ulcer surface area) were eligible for inclusion. Selection decisions were made by two review authors while working independently. DATA COLLECTION AND ANALYSIS Information on the characteristics of participants, interventions and outcomes was recorded on a standardised data extraction form. In addition, aspects of trial methods were extracted, including randomisation, allocation concealment, blinding of participants and outcome assessors, incomplete outcome data and study group comparability at baseline. Data extraction and validity assessment were conducted by one review author and were checked by a second. Data were pooled when appropriate. MAIN RESULTS Forty-five RCTs reporting 53 comparisons and recruiting a total of 4486 participants were included, Many RCTs were small, and most were at high or unclear risk of bias. Ulcer infection status at baseline and duration of follow-up varied across RCTs. Five RCTs reported eight comparisons of systemic antibiotics, and the remainder evaluated topical preparations: cadexomer iodine (11 RCTs reporting 12 comparisons); povidone-iodine (six RCTs reporting seven comparisons); peroxide-based preparations (four RCTs reporting four comparisons); honey-based preparations (two RCTs reporting two comparisons); silver-based preparations (12 RCTs reporting 13 comparisons); other topical antibiotics (three RCTs reporting five comparisons); and other topical antiseptics (two RCTs reporting two comparisons). Few RCTs provided a reliable estimate of time to healing; most reported the proportion of participants with complete healing during the trial period. Systemic antibioticsMore participants were healed when they were prescribed levamisole (normally used to treat roundworm infection) compared with placebo: risk ratio (RR) 1.31 (95% CI 1.06 to 1.62). No between-group differences were detected in terms of complete healing for other comparisons: antibiotics given according to antibiogram versus usual care; ciprofloxacin versus standard care/placebo; trimethoprim versus placebo; ciprofloxacin versus trimethoprim; and amoxicillin versus topical povidone-iodine. Topical antibiotics and antiseptics Cadexomer iodine: more participants were healed when given cadexomer iodine compared with standard care. The pooled estimate from four RCTs for complete healing at four to 12 weeks was RR 2.17 (95% CI 1.30 to 3.60). No between-group differences in complete healing were detected when cadexomer iodine was compared with the following: hydrocolloid dressing; paraffin gauze dressing; dextranomer; and silver-impregnated dressings.Povidone iodine: no between-group differences in complete healing were detected when povidone-iodine was compared with the following: hydrocolloid; moist or foam dressings according to wound status; and growth factor. Time to healing estimates for povidone-iodine versus dextranomer, and for povidone-iodine versus hydrocolloid, were likely to be unreliable.Peroxide-based preparations: four RCTs reported findings in favour of peroxide-based preparations when compared with usual care for surrogate healing outcomes (change in ulcer area). There was no report of complete healing.Honey-based preparations: no between-group difference in time to healing or complete healing was detected for honey-based products when compared with usual care.Silver-based preparations: no between-group differences in complete healing were detected when 1% silver sulphadiazine ointment was compared with standard care/placebo and tripeptide copper complex; or when different brands of silver-impregnated dressings were compared; or when silver-impregnated dressings were compared with non-antimicrobial dressings.Other topical antibiotics: data from one RCT suggested that more participants healed at four weeks when treated with an enzymatic cleanser (a non-antibiotic preparation) compared with a chloramphenicol-containing ointment (additional active ingredients also included in the ointment): RR 0.13 (95% CI 0.02 to 0.99). No between-group differences in complete healing were detected for framycetin sulphate ointment versus enzymatic cleanser; chloramphenicol ointment versus framycetin sulphate ointment; mupirocin ointment versus vehicle; and topical antibiotics given according to antibiogram versus an herbal ointment.Other topical antiseptics: data from one RCT suggested that more participants receiving an antiseptic ointment (ethacridine lactate) had responsive ulcers (defined as > 20% reduction in area) at four weeks when compared with placebo: RR 1.45 (95% CI 1.21 to 1.73). Complete healing was not reported. No between-group difference was detected between chlorhexidine solution and usual care. AUTHORS' CONCLUSIONS At present, no evidence is available to support the routine use of systemic antibiotics in promoting healing of venous leg ulcers. However, the lack of reliable evidence means that it is not possible to recommend the discontinuation of any of the agents reviewed. In terms of topical preparations, some evidence supports the use of cadexomer iodine. Current evidence does not support the routine use of honey- or silver-based products. Further good quality research is required before definitive conclusions can be drawn about the effectiveness of povidone-iodine, peroxide-based preparations, ethacridine lactate, chloramphenicol, framycetin, mupirocin, ethacridine or chlorhexidine in healing venous leg ulceration. In light of the increasing problem of bacterial resistance to antibiotics, current prescribing guidelines recommend that antibacterial preparations should be used only in cases of clinical infection, not for bacterial colonisation.
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Preoperative skin antiseptics for preventing surgical wound infections after clean surgery.
Dumville, JC, McFarlane, E, Edwards, P, Lipp, A, Holmes, A
The Cochrane database of systematic reviews. 2013;(3):CD003949
Abstract
BACKGROUND Surgical site infection rates in the month following clean surgery vary from 0.6% (knee prosthesis) to 5% (limb amputation). Due to the large number of clean surgical procedures conducted annually the costs of these surgical site infections (SSIs) can be considerable in financial and social terms. Preoperative skin antisepsis using antiseptics is performed to reduce the risk of SSIs by removing soil and transient organisms from the skin where a surgical incision will be made. Antiseptics are thought to be toxic to bacteria and therefore aid their mechanical removal. The effectiveness of preoperative skin preparation is thought to be dependent on both the antiseptic used and the method of application, however, it is unclear whether preoperative skin antisepsis actually reduces postoperative wound infection, and, if so, which antiseptic is most effective. OBJECTIVES To determine whether preoperative skin antisepsis immediately prior to surgical incision for clean surgery prevents SSI and to determine the comparative effectiveness of alternative antiseptics. SEARCH METHODS For this second update we searched the The Cochrane Wounds Group Specialised Register (searched 7 August 2012), The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7), Ovid MEDLINE (1950 to July Week 4 2012), Ovid MEDLINE (In-Process & Other Non-Indexed Citations August 06, 2012), Ovid EMBASE (1980 to 2012 Week 31), EBSCO CINAHL (2007 to 3 August 2012). SELECTION CRITERIA Randomised controlled trials evaluating the use of preoperative skin antiseptics applied immediately prior to incision in clean surgery. There was no restriction on the inclusion of reports based on language of publication, date or publication status. DATA COLLECTION AND ANALYSIS Data extraction and assessment of risk of bias were undertaken independently by two review authors. MAIN RESULTS Thirteen studies were included in this review (2,623 participants). These evaluated several different types of skin antiseptics - leading to 11 different comparisons being made. Although the antiseptics evaluated differed between studies, all trials involved some form of iodine. Iodine in alcohol was compared to alcohol alone in one trial; one trial compared povidone iodine paint (solution type not reported) with soap and alcohol. Six studies compared different types of iodine-containing products with each other and five compared iodine-containing products with chlorhexidine-containing products.There was evidence from one study suggesting that preoperative skin preparation with 0.5% chlorhexidine in methylated spirits led to a reduced risk of SSI compared with an alcohol based povidone iodine solution: RR 0.47 (95% CI 0.27 to 0.82). However, it is important to note that the trial does not report important details regarding the interventions (such as the concentration of povidone iodine paint used) and trial conduct, such that risk of bias was unclear.There were no other statistically significant differences in SSI rates in the other comparisons of skin antisepsis. Overall the risk of bias in included studies was unclear.A mixed treatment comparison meta-analysis was conducted and this suggested that alcohol-containing products had the highest probability of being effective - however, again the quality of this evidence was low. AUTHORS' CONCLUSIONS A comprehensive review of current evidence found some evidence that preoperative skin preparation with 0.5% chlorhexidine in methylated spirits was associated with lower rates of SSIs following clean surgery than alcohol-based povidone iodine paint. However this single study was poorly reported. Practitioners may therefore elect to consider other characteristics such as costs and potential side effects when choosing between alternatives.The design of future trials should be driven by the questions of high priority to decision makers. It may be that investment in at least one large trial (in terms of participants) is warranted in order to add definitive and hopefully conclusive data to the current evidence base. Ideally any future trial would evaluate the iodine-containing and chlorhexidine-containing solutions relevant to current practice as well as the type of solution used (alcohol vs. aqueous).
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Triclosan/copolymer containing toothpastes for oral health.
Riley, P, Lamont, T
The Cochrane database of systematic reviews. 2013;(12):CD010514
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BACKGROUND Periodontal disease and dental caries are highly prevalent oral diseases that can lead to pain and discomfort, oral hygiene and aesthetic problems, and eventually tooth loss, all of which can be costly to treat and are a burden to healthcare systems. Triclosan is an antibacterial agent with low toxicity, which, along with a copolymer for aiding retention, can be added to toothpastes to reduce plaque and gingivitis (inflammation of the gums). It is important that these additional ingredients do not interfere with the anticaries effect of the fluoride present in toothpastes, and that they are safe. OBJECTIVES To assess the effects of triclosan/copolymer containing fluoride toothpastes, compared with fluoride toothpastes, for the long-term control of caries, plaque and gingivitis in children and adults. SEARCH METHODS We searched the Cochrane Oral Health Group's Trials Register (to 19 August 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 7), MEDLINE via OVID (1946 to 19 August 2013), EMBASE via OVID (1980 to 19 August 2013), and the US National Institutes of Health Trials Register (clinicaltrials.gov) (to 19 August 2013). We applied no restrictions regarding language or date of publication in the searches of the electronic databases. SELECTION CRITERIA We included randomised controlled trials (RCTs) assessing the effects triclosan/copolymer containing toothpastes on oral health. DATA COLLECTION AND ANALYSIS Two review authors independently assessed the search results against the inclusion criteria for this review, extracted data and carried out risk of bias assessments. We attempted to contact study authors for missing information or clarification when feasible. We combined sufficiently similar studies in meta-analyses using random-effects models when there were at least four studies (fixed-effect models when fewer than four studies), reporting mean differences (MD) for continuous data and risk ratios (RR) for dichotomous data. MAIN RESULTS We included 30 studies, analysing 14,835 participants, in this review. We assessed 10 studies (33%) as at low risk of bias, nine (30%) as at high risk of bias and 11 (37%) as unclear. Plaque Compared with control, after six to seven months of use, triclosan/copolymer toothpaste reduced plaque by 0.47 on a 0 to 5 scale (MD -0.47, 95% confidence interval (CI) -0.60 to -0.34, 20 studies, 2675 participants, moderate-quality evidence). The control group mean was 2.17, representing a 22% reduction in plaque. After six to seven months of use, it also reduced the proportion of sites scoring 3 to 5 on a 0 to 5 scale by 0.15 (MD -0.15, 95% CI -0.20 to -0.10, 13 studies, 1850 participants, moderate-quality evidence). The control group mean was 0.37, representing a 41% reduction in plaque severity. Gingivitis After six to nine months of use, triclosan/copolymer toothpaste reduced inflammation by 0.27 on a 0 to 3 scale (MD -0.27, 95% CI -0.33 to -0.21, 20 studies, 2743 participants, moderate-quality evidence). The control group mean was 1.22, representing a 22% reduction in inflammation. After six to seven months of use, it reduced the proportion of bleeding sites (i.e. scoring 2 or 3 on the 0 to 3 scale) by 0.13 (MD -0.13, 95% CI -0.17 to -0.08, 15 studies, 1998 participants, moderate-quality evidence). The control group mean was 0.27, representing a 48% reduction in bleeding. Periodontitis After 36 months of use, there was no evidence of a difference between triclosan/copolymer toothpaste and control in the development of periodontitis (attachment loss) (RR 0.92, 95% CI 0.67 to 1.27, one study, 480 participants, low-quality evidence). Caries After 24 to 36 months of use, triclosan/copolymer toothpaste slightly reduced coronal caries when using the decayed and filled surfaces (DFS) index (MD -0.16, 95% CI -0.31 to -0.02, four studies, 9692 participants, high-quality evidence). The control group mean was 3.44, representing a 5% reduction in coronal caries. After 36 months of use, triclosan/copolymer toothpaste probably reduced root caries (MD -0.31, 95% CI -0.39 to -0.23, one study, 1357 participants, moderate-quality evidence). Calculus After six months of use, triclosan/copolymer toothpaste may have reduced the mean total calculus per participant by 2.12 mm (MD -2.12 mm, 95% CI -3.39 to -0.84, two studies, 415 participants, low-quality evidence). The control group mean was 14.61 mm, representing a 15% reduction in calculus. Adverse effects There were no data available for meta-analysis regarding adverse effects, but 22 studies (73%) reported that there were no adverse effects caused by either the experimental or control toothpaste.There was considerable heterogeneity present in the meta-analyses for plaque, gingivitis and calculus. Plaque and gingivitis showed such consistent results that it did not affect our conclusions, but the reader may wish to interpret the results with more caution. AUTHORS' CONCLUSIONS There was moderate-quality evidence showing that toothpastes containing triclosan/copolymer, in addition to fluoride, reduced plaque, gingival inflammation and gingival bleeding when compared with fluoride toothpastes without triclosan/copolymer. These reductions may or may not be clinically important, and are evident regardless of initial plaque and gingivitis levels, or whether a baseline oral prophylaxis had taken place or not. High-quality evidence showed that triclosan/copolymer toothpastes lead to a small reduction in coronal caries. There was weaker evidence to show that triclosan/copolymer toothpastes may have reduced root caries and calculus, but insufficient evidence to show whether or not they prevented periodontitis. There do not appear to be any serious safety concerns regarding the use of triclosan/copolymer toothpastes in studies up to three years in duration.
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9.
Antibiotics and antiseptics for venous leg ulcers.
O'Meara, S, Al-Kurdi, D, Ologun, Y, Ovington, LG, Martyn-St James, M, Richardson, R
The Cochrane database of systematic reviews. 2013;(12):CD003557
Abstract
BACKGROUND Venous leg ulcers are a type of chronic wound affecting up to 1% of adults in developed countries at some point during their lives. Many of these wounds are colonised by bacteria or show signs of clinical infection. The presence of infection may delay ulcer healing. Two main strategies are used to prevent and treat clinical infection in venous leg ulcers: systemic antibiotics and topical antibiotics or antiseptics. OBJECTIVES The objective of this review was to determine the effects of systemic antibiotics and topical antibiotics and antiseptics on the healing of venous ulcers; review authors also examined the effects of these interventions on clinical infection, bacterial flora, bacterial resistance, ulcer recurrence, adverse effects, patient satisfaction, health-related quality of life and costs. SEARCH METHODS In May 2013, for this second update, we searched the Cochrane Wounds Group Specialised Register (searched 24 May 2013); the Cochrane Central Register of Controlled Trials (CENTRAL 2013, Issue 4); Ovid MEDLINE (1948 to Week 3 May 2013); Ovid MEDLINE (In-Process & Other Non-indexed Citations, 22 May 2013); Ovid EMBASE (1980 to Week 20 2013); and EBSCO CINAHL (1982 to 17 May 2013). No language or publication date restrictions were applied. SELECTION CRITERIA Randomised controlled trials (RCTs) recruiting people with venous leg ulceration, evaluating at least one systemic antibiotic, topical antibiotic or topical antiseptic that reported an objective assessment of wound healing (e.g. time to complete healing, frequency of complete healing, change in ulcer surface area) were eligible for inclusion. Selection decisions were made by two review authors while working independently. DATA COLLECTION AND ANALYSIS Information on the characteristics of participants, interventions and outcomes was recorded on a standardised data extraction form. In addition, aspects of trial methods were extracted, including randomisation, allocation concealment, blinding of participants and outcome assessors, incomplete outcome data and study group comparability at baseline. Data extraction and validity assessment were conducted by one review author and were checked by a second. Data were pooled when appropriate. MAIN RESULTS Forty-five RCTs reporting 53 comparisons and recruiting a total of 4486 participants were included, Many RCTs were small, and most were at high or unclear risk of bias. Ulcer infection status at baseline and duration of follow-up varied across RCTs. Five RCTs reported eight comparisons of systemic antibiotics, and the remainder evaluated topical preparations: cadexomer iodine (11 RCTs reporting 12 comparisons); povidone-iodine (six RCTs reporting seven comparisons); peroxide-based preparations (four RCTs reporting four comparisons); honey-based preparations (two RCTs reporting two comparisons); silver-based preparations (12 RCTs reporting 13 comparisons); other topical antibiotics (three RCTs reporting five comparisons); and other topical antiseptics (two RCTs reporting two comparisons). Few RCTs provided a reliable estimate of time to healing; most reported the proportion of participants with complete healing during the trial period. Systemic antibioticsMore participants were healed when they were prescribed levamisole (normally used to treat roundworm infection) compared with placebo: risk ratio (RR) 1.31 (95% CI 1.06 to 1.62). No between-group differences were detected in terms of complete healing for other comparisons: antibiotics given according to antibiogram versus usual care; ciprofloxacin versus standard care/placebo; trimethoprim versus placebo; ciprofloxacin versus trimethoprim; and amoxicillin versus topical povidone-iodine. Topical antibiotics and antisepticsCadexomer iodine: more participants were healed when given cadexomer iodine compared with standard care. The pooled estimate from four RCTs for complete healing at four to 12 weeks was RR 2.17 (95% CI 1.30 to 3.60). No between-group differences in complete healing were detected when cadexomer iodine was compared with the following: hydrocolloid dressing; paraffin gauze dressing; dextranomer; and silver-impregnated dressings.Povidone iodine: no between-group differences in complete healing were detected when povidone-iodine was compared with the following: hydrocolloid; moist or foam dressings according to wound status; and growth factor. Time to healing estimates for povidone-iodine versus dextranomer, and for povidone-iodine versus hydrocolloid, were likely to be unreliable.Peroxide-based preparations: four RCTs reported findings in favour of peroxide-based preparations when compared with usual care for surrogate healing outcomes (change in ulcer area). There was no report of complete healing.Honey-based preparations: no between-group difference in time to healing or complete healing was detected for honey-based products when compared with usual care.Silver-based preparations: no between-group differences in complete healing were detected when 1% silver sulphadiazine ointment was compared with standard care/placebo and tripeptide copper complex; or when different brands of silver-impregnated dressings were compared; or when silver-impregnated dressings were compared with non-antimicrobial dressings.Other topical antibiotics: data from one RCT suggested that more participants healed at four weeks when treated with an enzymatic cleanser (a non-antibiotic preparation) compared with a chloramphenicol-containing ointment (additional active ingredients also included in the ointment): RR 0.13 (95% CI 0.02 to 0.99). No between-group differences in complete healing were detected for framycetin sulphate ointment versus enzymatic cleanser; chloramphenicol ointment versus framycetin sulphate ointment; mupirocin ointment versus vehicle; and topical antibiotics given according to antibiogram versus an herbal ointment.Other topical antiseptics: data from one RCT suggested that more participants receiving an antiseptic ointment (ethacridine lactate) had responsive ulcers (defined as > 20% reduction in area) at four weeks when compared with placebo: RR 1.45 (95% CI 1.21 to 1.73). Complete healing was not reported. No between-group difference was detected between chlorhexidine solution and usual care. AUTHORS' CONCLUSIONS At present, no evidence is available to support the routine use of systemic antibiotics in promoting healing of venous leg ulcers. However, the lack of reliable evidence means that it is not possible to recommend the discontinuation of any of the agents reviewed. In terms of topical preparations, some evidence supports the use of cadexomer iodine. Current evidence does not support the routine use of honey- or silver-based products. Further good quality research is required before definitive conclusions can be drawn about the effectiveness of povidone-iodine, peroxide-based preparations, ethacridine lactate, chloramphenicol, framycetin, mupirocin, ethacridine or chlorhexidine in healing venous leg ulceration. In light of the increasing problem of bacterial resistance to antibiotics, current prescribing guidelines recommend that antibacterial preparations should be used only in cases of clinical infection, not for bacterial colonisation.
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10.
Prevention of ventilator-associated pneumonia with oral antiseptics: a systematic review and meta-analysis.
Labeau, SO, Van de Vyver, K, Brusselaers, N, Vogelaers, D, Blot, SI
The Lancet. Infectious diseases. 2011;(11):845-54
Abstract
BACKGROUND We did a systematic review and random effects meta-analysis of randomised trials to assess the effect of oral care with chlorhexidine or povidone-iodine on the prevalence of ventilator-associated pneumonia versus oral care without these antiseptics in adults. METHODS Studies were identified through PubMed, CINAHL, Web of Science, CENTRAL, and complementary manual searches. Eligible studies were randomised trials of mechanically ventilated adult patients receiving oral care with chlorhexidine or povidone-iodine. Relative risks (RR) and 95% CIs were calculated with the Mantel-Haenszel model and heterogeneity was assessed with the I(2) test. FINDINGS 14 studies were included (2481 patients), 12 investigating the effect of chlorhexidine (2341 patients) and two of povidone-iodine (140 patients). Overall, antiseptic use resulted in a significant risk reduction of ventilator-associated pneumonia (RR 0.67; 95% CI 0.50-0.88; p=0.004). Chlorhexidine application was shown to be effective (RR 0.72; 95% CI 0.55-0.94; p=0.02), whereas the effect resulting from povidone-iodine remains unclear (RR 0.39; 95% CI 0.11-1.36; p=0.14). Heterogeneity was moderate (I(2)=29%; p=0.16) for the trials using chlorhexidine and high (I(2)=67%; p=0.08) for those assessing povidone-iodine use. Favourable effects were more pronounced in subgroup analyses for 2% chlorhexidine (RR 0.53, 95% CI 0.31-0.91), and in cardiosurgical studies (RR 0.41, 95% CI 0.17-0.98). INTERPRETATION This analysis showed a beneficial effect of oral antiseptic use in prevention of ventilator-associated pneumonia. Clinicians should take these findings into account when providing oral care to intubated patients. FUNDING None.