Comparative Effects of Recove® and Nitrofurazone 0.2% on the Treatment of First and Second-Degree Burns: a Double-Blind Randomized Clinical Trial.

Background: Burns are among the major health challenges of all societies and more than any other trauma incur physical, mental, social, and economic burdens on the patient and society. This study was conducted to assess whether Recove® burn ointment is capable of alleviating the pain, preventing the formation of new blisters and controlling the microbial contamination of the wound. Methods: We, therefore, compared its efficacy to ​​nitrofurazone 0.2% cream. This randomized clinical trial was conducted on individuals who had two burn injuries in their body at the same time in the Motahari Burn Hospital, Tehran Province, from June to October 2016. Sampling was carried out with a non-random method using available samples. The intervention in experimental and control groups was Recove® and nitrofurazone, respectively. The effect of interventions on pain relief, the formation of new blisters and prevention of infection at the burn wound were evaluated. In our double-blind study, blindness was applied to the patients and the person evaluating the outcomes. Results: Both Recove® and nitrofurazone interventions significantly alleviated pain (P < 0.01), but Recove ®showed more effectiveness (P=0.01). Similarly, in terms of new blister formation, the experimental group receiving Recove® showed less new blister formation over 24 hours after treatment compared to nitrofurazone group (P=0.03) and with respect to antimicrobial activity, there was no significant difference between Recove® and nitrofurazone (P=0.12). Conclusion: Recove® was effective on pain reduction, prevention of new blisters formation as well as infection. Therefore, it seems that Recove® could be considered as a new and efficient treatment for burn.

A randomized, double-blind, phase I clinical trial of fetal cell-based skin substitutes on healing of donor sites in burn patients.

BACKGROUND: Due to limited graft donor sites in extensive burns, re-harvesting of a single donor area is very common. Given the importance of fetal fibroblasts in accelerating fetal wound healing, fetal cell-based skin substitutes have emerged as a novel therapeutic modality for regenerating damaged skin. In this trial, we aimed to evaluate the safety, feasibility and potential efficacy of application of amniotic membranes seeded with fetal fibroblasts for accelerating donor sites healing in burn patients. METHODS: In this randomized, double-blind, phase I clinical trial, 10 patients with total burn surface area of 10-55% were enrolled. Three equal parts (10×10cm) were selected in donor site of each patient and covered by Vaseline gauze (control group), amniotic membrane (AM group), or amniotic membrane seeded with fetal fibroblasts (AM-F group). Adverse events, pain intensity scores, and wound sizes were recorded on days 4, 8, 11, 14, and 20 post-treatment. Also, histological assessments were done on days 0 and 14 after the surgery. RESULTS: All patients underwent surgery, and no adverse events occurred during the procedure and follow-up period. Significantly lower pain intensity and higher healing rates were observed in AM-F and AM groups compared to the control group. Moreover, mean complete re-epithelializatin in AM-F and AM groups were 10.1±2.4 and 11.3±2.9 days, showing that the healing process was significantly accelerated compared to the control group with mean closure time of 14.8±1.6 days. Histological assessment showed lower inflammatory cells infiltration in AM-F and AM groups compared to control group. CONCLUSIONS: This study indicated the safety of transplantation of amniotic membrane seeded with fetal fibroblasts for treatment of donor sites in burn patients; however, preliminary assessments showed no benefits for this therapeutic modality over amniotic membrane alone. Thus, to draw accurate conclusions, further trials in larger populations should be conducted. LEVEL OF EVIDENCE: This study is assigned as level I.