Effectiveness, Safety, and Satisfaction of Silicone Pro Gel in Prophylaxis and Management of Post-Operative Scar: A Randomized, Double-Blinded, Placebo-Controlled Study
Thamkhantho M, Chayahinda C*, Leeyaphan C
Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, 2 Wang Lang Road, Bangkoknoi, Bangkok 10700, Thailand. Phone: +66-2-4194775, Fax: +66-2-4194997; Email: chenchit.cha@mahidol.ac.th
Background: To assess the effectiveness and side effects of Silicone Pro Gel to alleviate scar development among the pregnant women with the first cesarean section, and their satisfaction.
Materials and Methods: The present study was a randomized, double-blinded, placebo-controlled study among the women with transverse abdominal wound of the first cesarean section. The formation and improvement of scar was assessed by intervention blinded investigators and patients in terms of redness, height, surface regularity, and attribute of the scar. Ninety women were enrolled into either the study drug or placebo groups by computerized randomization (C0). Women in both groups applied the allocated drugs within 7 to 10 days after cesarean section and had to apply the allocated drugs twice a day. The re-assessment was done at 28±4 days (C1), at 56±4 days (C2) and at 84±4 days (C3).
Results: About 76% of women completed the study. The present study product performed better than the placebo in terms of formation of the wound, including height, surface regularity, and attribute of the scar. Neither side effects nor serious complications caused by the study drug were reported. Most women reported high satisfaction and there was no difference of participants’ perception toward the wound between groups
Conclusion: Silicone Pro Gel performed better in terms of alleviation of scar development post cesarean section with high participants’ satisfaction.
วารสารจดหมายเหตุทางการแพทย์ ปี 2563, May ปีที่: 103 ฉบับที่ 5 หน้า 442-448
Scar, Photograph assessment, Investigator, Participant