Cameron 1991.
Methods | Randomised controlled trial conducted in the UK | |
Participants | 30 people with venous leg ulcers:
Group 1: 15
Group 2: 15 Mean baseline ulcer area (cm2—variability data not reported): Group 1: 17.3. Group 2: 16.3 Mean (range) baseline ulcer duration: Group 1: 6 years (1 month to 36 years); Group 2: 2.7 years (6 months to 9 years) 5 participants in each group had Gram‐positive bacteria present in their wounds at baseline. There was no report of signs and symptoms of clinical infection. |
|
Interventions | 1. White soft paraffin tulle gras and compression therapy 2. Mupirocin‐impregnated tulle gras and compression therapy | |
Outcomes | After 12 weeks complete healing:
1. 46%
2. 53% Mean percentage change in ulcer area: 1. 68% 2. 50% Eradication of Gram‐positive bacteria 1. 0/5 2. 5/5 |
|
Notes | No withdrawals reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomised into 2 treatment groups" Comment: It was not stated how the sequence was generated |
Allocation concealment (selection bias) | Unclear risk | Quote: "patients were randomised into 2 treatment groups" Comment: allocation concealment was not mentioned |
Blinding (performance bias and detection bias) Participant blinded to the intervention | Low risk | Quote: "The study was a randomised double‐blind placebo controlled pilot study" |
Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention | Unclear risk | Quote: "The study was a randomised double blind placebo controlled pilot study" Comment: It was not stated that outcome assessors were blinded |
Incomplete outcome data (attrition bias) Drop out rate described | Unclear risk | 30 patients were recruited; no withdrawals were reported |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Unclear risk | Withdrawal rate was not described |
Incomplete outcome data (attrition bias) ITT analysis | Unclear risk | Method of analysis not described |
Baseline factors comparable | High risk | The ulcers in Group 1 had longer mean duration than those in Group 2 (2.7 years versus 6 years) |