Guilbaud 1993.
Methods | RCT. Method of randomisation, allocation concealment and blinding of participants and investigators (including outcome assessors) not reported. | |
Participants | 93 patients (mean age 35.7 years) with second‐degree burns admitted within 48 hours of injury. Mean %TBSA not described. | |
Interventions | Hydrogel dressing versus SSD, paraffin gauze or paraffin gauze with antibiotics or topical antibiotics | |
Outcomes | Time to complete wound healing Level of pain Number of dressing changes | |
Notes | Withdrawals
I: 8/93 (9%)
C: 8/93 (9%) Loss to follow‐up I: 8/93 (9%) C: 8/93 (9%) |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised allocation list |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | High risk | Trial described as "open" with each participant acting as his own control. Investigator and patient not blinded (investigator chose the control treatment for individual patients) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Withdrawals from each subgroup as follows: (1) second‐degree burns 8/93 (9%); (2) donor sites 29/164 (18%); (3) meshed skin grafts 27/107 (25%); (4) loss of skin substance 20/96 (21%). The majority of withdrawals were from the experimental group, as proscribed in the protocol. |
Selective reporting (reporting bias) | High risk | Adverse events not reported |
Other bias | High risk | (1) Patients acted as own control, giving rise to potential unit of analysis errors; assessment of pain (one of the outcomes) thus not independent; (2) selection of control by investigators; (3) change of dressings at the discretion of the investigators; (4) selection of control sites in same patient made subjectively to ensure similarity with experimental site; (5) care protocols not identical: changes in dressings in experimental group led to withdrawal from the trial, but this was not required in the control group; (6) dressings supplied by company that manufactures them; no guarantees given that results safeguarded from company influence |