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, MD, FRCOG, MSc¹, Chayachinda C, MD, MSc¹, Leeyaphan C, MD, MSc²
Affiliation : ¹ Department of Obstetrics and Gynecology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand ² Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
Objective: 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.
Received 27 Mar 2020 | Revised 7 Apr 2020 | Accepted 10 Apr 2020
Keywords : Scar, Photograph assessment, Investigator, Participant
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