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. 2013 Mar 28;2013(3):CD002106. doi: 10.1002/14651858.CD002106.pub4

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