Beitner 1985a.
| Methods | Randomised controlled trial conducted in Sweden. Each participant had 2 leg ulcers each and acted as his or her own control. Ulcers were the unit of randomisation | |
| Participants | 10 participants (20 ulcers) were recruited. There were no details of baseline characteristics, including ulcer infection status | |
| Interventions | Interventions were applied to 10 participants with 2 leg ulcers each, acting as his or her own control. For each participant, one ulcer was treated with 10% benzoyl peroxide lotion and the other with normal saline solution. For both ulcers, treatment was applied by moistening a sterile sponge compress, cut to the exact shape of the ulcer, with the respective solution. The sponge dressings were then covered with a thick pad and kept in place with a gauze stocking. The ulcer margins were protected with zinc ointment, and a supporting elastic bandage was applied. Dressings were changed 3 times a week for 42 days | |
| Outcomes | Mean ± SD percentage ulcer area remaining at 42 days:
Normal saline solution 94.7% ± 12.7% 10% benzoyl peroxide lotion 64.3% ± 14.0% Adverse effects: 3 participants reported severe irritation from use of 10% benzoyl peroxide lotion. No information about adverse effects for ulcers treated with the normal saline solution |
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| Notes | 3 participants withdrew; it was not stated whether withdrawal was related to adverse effects (severe irritation from use of 10% benzoyl peroxide lotion). This trial report described 3 separate RCTs recruiting 31 participants in total. All participants had 2 leg ulcers each and acted as his or her own control. One other RCT was included (Beitner 1985b) and the other was excluded (Beitner 1985c). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The ulcer chosen for BPO treatment was randomised according to left or right leg and most distal or proximal location. When ulcers were situated at the same level, medial or lateral localization was randomised" Comment: the sequence generation method was not stated |
| Allocation concealment (selection bias) | High risk | Quote: "the randomisation and treatment was given in the day care unit by personnel not involved in the evaluation of results" Comment: the information provided suggests that group allocation was likely to be unconcealed |
| Blinding (performance bias and detection bias) Participant blinded to the intervention | Unclear risk | Comment: no information provided |
| Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention | Unclear risk | Quote: "the randomisation and treatment was given in the day care unit by personnel not involved in the evaluation of results" Comment: no statement that outcome assessors were blind to treatment allocation |
| Incomplete outcome data (attrition bias) Drop out rate described | Low risk | Comment: clearly stated that 3 participants withdrew, and reasons provided |
| Incomplete outcome data (attrition bias) Drop out rate acceptable | High risk | Comment: 3/10 (30%) participants withdrew |
| Incomplete outcome data (attrition bias) ITT analysis | Unclear risk | Comment: no information provided |
| Baseline factors comparable | Unclear risk | Comment: no information provided on baseline characteristics of participants/ulcers in each group |