The impact of an open-label design on human amniotic membranes vs. silver sulfadiazine dressings for second-degree burns: a randomized controlled clinical trial

Moghimi, Mohammad Hossein; Salehian, Mehran; Abdi, Mohammad; Tahrekhani, Mehran; Safaei, Alireza; Kamali, Koorosh

Abstract

Background: Burn wounds require optimal medical management due to associated psycho-emotional and socioeconomic impacts and severe pain. The use of synthetic and biological dressings improves healing and reduces burn wound complications. The present study aimed to compare the outcomes of using human amniotic membrane (hAM) dressings and conventional silver sulfadiazine (SSDZ) ointment dressings in the management of second-degree burn wounds.

Methods: Fifty patients who participated in this clinical trial were divided into two groups via simple randomization. All the enrolled patients, who had burnt in the last 24 h, had thermal damage mechanisms and were suffering from less than 20% second-degree heat-burn wounds on the skin surface. The target group (n = 25) was treated with hAM, and the control group (n = 25) was treated with SSDZ ointment. The researcher-designed checklist was used to determine the clinical performance in the follow-up assessments on days 7, 14, and 30.

Results: No significant differences were detected in terms of sex, age, or percentage of burn wounds (p > 0.05). Wound epithelialization at days 7, 14, and 30, scar formation, wound pigmentation, pain severity, analgesia requirements, and hospital stay length (on day 30) were significantly lower in the target group (treated with hAM) than in the control group (treated with SSDZ ointment) (p < 0.05). However, treatment costs in the target group ($170) were significantly higher than those in the control group ($71) (p < 0.001).

Conclusion: Despite its higher cost, hAM, as a technology-based therapy dressing, demonstrates superiority over SSDZ ointment in terms of wound healing and pain management.

Citation

Moghimi, M. H., Salehian, M., Abdi, M., Tahrekhani, M., Safaei, A., & Kamali, K. (in press). The impact of an open-label design on human amniotic membranes vs. silver sulfadiazine dressings for second-degree burns: a randomized controlled clinical trial. BMC Surgery, 24(1), Article 309. https://doi.org/10.1186/s12893-024-02554-5

• Journal Article Type: Article
• Acceptance Date: Sep 2, 2024
• Online Publication Date: Oct 14, 2024
• Deposit Date: Oct 24, 2024
• Publicly Available Date: Oct 24, 2024
• Journal: BMC Surgery
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 24
• Issue: 1
• Article Number: 309
• DOI: https://doi.org/10.1186/s12893-024-02554-5
• Keywords: Clinical trial, Burns, Amniotic membrane, Silver sulfadiazine