Nursing Practice ● The Cochrane Nursing Care Field writes Exclusive Cochrane summary exclusively for Nursing Wound care Times readers The presence of leg-ulcer infection may delay healing. A Cochrane review has found no evidence to support the routine use of systemic antibiotics as agents to promote the healing of venous leg ulcers Use of systemic antibiotics and antiseptics for venous leg ulcers 5 key In this article... points Evidence on systemic antibiotics for wound infection Venous leg Comparison between topical preparations 1ulcers affect The limitations of current evidence up to 1% of adults in developed countries Author Marinha Sofia Macedo is clinical reported. Five RCTs reported eight com- Leg ulcers can instructor for nursing research, nursing parisons of systemic antibiotics and the 2take years to development and Saudization, Nursing remaining studies compared topical prep- heal and are Research Division, King Faisal Specialist arations: cadexomer iodine, povidone- associated with Hospital and Research Centre, Riyadh, iodine, peroxide-based preparations, significant costs Saudi Arabia, and member of the honey-based preparations, silver-based Main strategies Cochrane Nursing Care Field (CNCF). preparations, topical antibiotics and other 3for leg-ulcer Abstract Macedo MS (2014) Use of systemic topical antiseptics. treatment are antibiotics and antiseptics for venous leg Participants could be treated in any compression ulcers. Nursing Times; 110: 25, 16-17. care setting and were those presenting with therapy, dressings A Cochrane review has brought together venous leg ulcers, as defined by the study and antimicrobial the available evidence on the use of author, or various wounds if the venous- therapy systemic antibiotics and topical antibiotics ulcer results were reported distinctly. The Antibiotics and antiseptics for infected leg ulcers. This intervention arm included antibiotics (top- 4should not be article presents a summary of the evidence ical or systemic, oral or intravenous) and used when wounds and describes its limitations. topical antiseptics. No specifications on are colonised but strength or duration were noted. The com- not infected enous leg ulcers are a type of parison arm was either a placebo, an alter- More research chronic wound that affects up to native antibiotic or antiseptic, any other 5is needed into 1% of adults in developed coun- therapy, usual care or no treatment. the effectiveness Vtries during their lives. These The primary outcome was wound of treatments for wounds can be slow to heal – from a few healing, which could be measured as time wound infection weeks to more than 10 years – and, in some to complete wound healing, proportion of cases, never do so. They are usually associ- wounds healed during follow-up, and ated with significant cost to patients and changes in wound size when compared healthcare systems. with size at baseline. Secondary outcomes The main strategies to treat venous were changes in signs and symptoms of ulcers are compression therapy, primary clinical infection, changes in bacterial flora, wound contact dressings and antimicrobial development of bacterial resistance, ulcer therapy when the wound is thought to be recurrence rates, adverse events, partici- infected. Two main approaches to manage pant satisfaction and health-related quality clinical infection in venous leg ulcers are: of life, and costs. » Systemic and topical antibiotics; Of the studies, three had low risk of bias » Antiseptics. (one on honey-based preparations and two A systematic review was undertaken to on silver-based preparations), 13 high risk of determine the effects of antibiotics and bias and 29 were at an unclear risk of bias. antiseptics on venous ulcers. Meta-analysis was done where possible.
Review process Findings The review involved 45 randomised con- Systemic antibiotics trolled trials with a total of 4,486 partici- Five studies involving a total of 233 partici- Many treatments are used to treat infected
Alamy pants, from which 53 comparisons were pants looked at systemic antibiotics. venous leg ulcers but not all are effective
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They found the following: difference in healing between treatment was found between wounds treated with » Comparing co-trimaxazole, gentamicin groups in one trial comparing moist or chlorhexidine solution and usual care in or amikacin with standard care showed foam dressings with povidone-iodine. terms of time to healing. no significant difference in healing (one Two RCTs reported lower costs associated study); with povidone-iodine but a full economic Adverse events » Ciprofloxacin versus standard care or analysis was not presented for either trial. More participants reported adverse events placebo demonstrated no difference in for cadexomer iodine relative to standard complete healing at 3-4 months (two Peroxide-based preparations. Four trials (72 care. Severe irritations were associated studies); participants) tested peroxide-based prepa- with benzoyl peroxide; more frequent » Ciprofloxacin versus trimethoprim rations. Benzoyl peroxide 10% and 20% was adverse events were reported relative to showed no significant difference in significantly more effective than saline in honey-based preparations. healing (one study); terms of ulcer area remaining (one trial » Trimethoprim versus placebo showed each). Hydrogen peroxide 1% cream com- Conclusion no significant difference in healing pared with placebo resulted in significantly The studies did have some limitations: (one study); greater wound-area reduction (two trials). many were small and most were at high or » Amoxicillin versus topical povidone- unclear risk of bias. The review concludes: iodine showed no difference between Honey-based preparations. These were the » Evidence from RCTs of participants groups in complete healing (one study). subject of two multicentre RCTs with 476 with infected wounds is sparse; The limited data suggested recurrence participants. The first found no difference » It is difficult to interpret the effects of of ulcer infection was lower for in complete healing when the preparations antibiotics and antiseptics on healing povidone-iodine; were compared with hydrogels; the second and infection; » All ulcers treated with levamisole healed compared them with non-honey impreg- » No evidence is available to support the compared with 76% in the placebo nated dressings and found no difference in routine use of systemic antibiotics to group (one study). The review says this time to healing and change in health- promote healing venous leg ulcers; trial was small, so the effect could have related quality of life. » The lack of reliable evidence means it is occurred by chance. Three patients not possible to recommend the reported gastric adverse events. Silver-based preparations. A total of 12 RCTs discontinuation of any of the agents; with 1,514 participants, making 13 compari- » Levamisole was the only systemic Topical antibiotics and antiseptics sons, provided evidence on creams and antibiotic with evidence of benefit in Cadexomer iodine. The evidence on cadex- dressings containing silver. No differences terms of ulcer healing; omer iodine came from 11 RCTs with 922 were found between treatment groups » Some evidence supports the use of participants; seven trials compared it with when silver sulphadiazine cream was com- cadexomer iodine as a topical standard care. Data from four RCTs were pared with usual care (one trial), placebo preparation but it was linked to more pooled for the outcome of complete healing (one trial), non-adherent dressings (one adverse events than usual care; at 4-12 weeks, indicating 33% healed when trial) or growth factor (one trial). Compar- » Evidence does not support using given cadexomer iodine and 15% healed on ison between different silver-impregnated honey- or silver-based preparations; standard care. No differences in healing dressings found no difference between » The increase of bacterial resistance to were found when cadexomer iodine was groups (one trial); a further eight trials antibiotics means these are only compared with hydrocolloid dressings found no difference between silver-impreg- recommended in cases of clinical (one trial) paraffin gauze dressings (one nated and non-antimicrobial dressings. infection, not bacterial colonisation. NT trial), dextranomer (two trials) or silver- impregnated dressings (one trial). Other topical antibiotics and antiseptics. Five ● The full review is: O´Meara S et al (2014) RCTs (590 participants) provided evidence Antibiotics and antiseptics for venous leg Povidone-iodine. This was studied in six RCTs on other topical antibiotics and antiseptics. ulcers. Cochrane Database of Systematic (639 participants). When compared with For topical antibiotics, one RCT sug- Reviews. Issue 1. tinyurl.com/Cochrane- dextranomer in one trial, the mean time to gested an increase in the proportion healed wound-infection healing was shorter in the dextranomer at four weeks when patients were treated group (4.4 weeks versus 5.3 weeks) as was with enzymatic cleanser compared with time to eradication of Staphylococcus aureus chloramphenicol-containing ointment. recommendations colonisation (14.7 days versus 18.7 days). No differences were found between groups However, this data should be interpreted in complete healing for: framycetin sul- ● Do not routinely use systemic with caution as the analysis method used by phate ointment and enzymatic cleanser; antibiotics the trial authors was deemed inappropriate. chloramphenicol ointment and framy- ● Do not discontinue use of any of the When povidone-iodine was compared cetin sulphate ointment; mupirocin oint- agents with growth factor (one RCT) and hydro- ment and vehicle; and topical antibiotics ● Cadexomer iodine can be used but colloid dressings (three trials), there was given according to antibiogram (in vitro has been associated with more adverse no difference in healing between treat- testing) and herbal ointment. events than usual care ment groups. When one trial compared it For topical antiseptics, data from one ● Do not use honey- and silver-based with a non-adherent paraffin-gauzeRCT suggested ulcers would present a preparations dressing, there was a statistically signifi- better response (>20% area reduction) ● Antibiotics are recommended only in cant difference in ulcer-area reduction at when treated with an antiseptic ointment, cases of clinical infection, not in three months in favour of hyaluronic acid/ ethacridine lactase compared with a pla- bacterial colonisation povidone-iodine dressing. There was no cebo. No statistically significant difference
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