Healy 1989.
Methods | Country where data collected: UK Parallel‐group RCT Unit of randomisation: participant Unit of analysis: participant Duration: Up to 14 days |
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Participants | Inclusion criteria: people with partial‐thickness burns covering < 10% TBSA Exclusion criteria: burns to face and hands Participants: 32 individuals with burns (no further information) Mean age (years): 2.6 (includes 0 adults) versus 20.6 (includes 5 adults) Male participants: NR Burn type: scald 25, flame 6, contact 1 (numbers approximately equal between groups) Burn degree: partial‐thickness Burn size (%TBSA): 1.8 ± 0.8 vs 2.3 ± 0.6 Burn location: NR |
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Interventions | Intervention arm 1: silver‐impregnated porcine xenograft (E‐Z Derm) N = 16 Intervention arm 2: petroleum gauze (Jelonet) N = 16 Cointerventions: NR |
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Outcomes | Primary outcome: wound healing Secondary outcome: adverse events (need for surgery) |
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Notes | Funding NR | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomization to either the E‐Z Derm or Jelonet groups was by drawing a card from a sealed envelope." Comment: unclear how the randomisation process was designed and implemented so unclear if truly random |
Allocation concealment (selection bias) | Unclear risk | Quote: "Randomization to either the E‐Z Derm or Jelonet groups was by drawing a card from a sealed envelope." Comment: unclear whether allocation was adequately concealed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "All of the burns in both groups were assessed for the following: I. The need for surgical intervention to achieve healing............2. The time to spontaneous healing was noted in those patients not requiring surgical treatment. 3. Laboratory reports of significant growths of pathogenic microorganisms on culture of superficial wound swabs" Comment: no indication that assessment was carried out in a blinded manner |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no specific quote but all randomised participants appeared to be included in the analysis (based on tables) |
Selective reporting (reporting bias) | Low risk | Quote: "All of the burns in both groups were assessed for the following: I. The need for surgical intervention to achieve healing, indicated by clinical evidence of an increase in burn depth and lack of evidence of spontaneous healing by 10‐14 days. 2. The time to spontaneous healing was noted in those patients not requiring surgical treatment. 3. Laboratory reports of significant growths of pathogenic microorganisms on culture of superficial wound swabs." Comment: specified outcomes were properly reported. |
Other bias | Unclear risk | Comment: no specific quote but no evidence of other sources of bias, but reporting insufficient to be certain |