Comparative evaluation of silver sulfadiazine cream and povidone-iodine in the management of moderate-to-severe burn wounds: a double-blind clinical trial

Burn injuries remain a major public health concern, often resulting in extensive tissue damage and life-threatening complications. Among these, burn wound infections are the leading cause of mortality in patients with extensive surface area involvement. This study aimed to compare the wound-healing efficacy of silver sulfadiazine (SSD) cream and povidone-iodine in patients with second- and third-degree burns involving 30 to 50% of total body surface area (TBSA). The primary outcome was wound healing rate (time to graft preparation), while secondary outcomes included pain intensity and the frequency of required dressing changes. In this double-blind clinical trial, 80 patients with second- or third-degree burns involving 30 to 50% TBSA were enrolled and randomly assigned to receive either SSD cream or povidone-iodine (PI). The sample size was determined using a formal power calculation (α = 0.05, power = 80%), resulting in 40 patients per group. Wound healing was assessed based on healing rate, tissue appearance, pain intensity, inflammatory response, and overall recovery, using weekly clinical examinations and photographic documentation. Among the 80 participants (51.2% female and 48.8% male; mean age, 38.1 ± 14 years), the PI group required significantly more frequent dressing changes (P = 0.001) and reported higher pain intensity (P < 0.001). Interestingly, no significant between-group differences were observed in healing rate, number of surgical interventions, or length of hospital stay (P > 0.05). Logistic regression identified pain intensity as the only variable significantly associated with treatment type (P = 0.014). SSD demonstrated superior clinical performance in reducing pain and dressing frequency among patients with moderate-to-severe burns, although overall healing rates were comparable between groups. Larger multicenter studies are recommended to validate these findings and to assess long-term outcomes.Clinical trial registration Iranian Registry of Clinical Trials (IRCT), IRCT20240126060819N1, registered on April 10, 2024.