Monoglyde suture study PP data

This is a prospective, single-blind, randomized (1:1), multicentric, two-arm study. The primary objective was to compare subcuticular skin closure with Monoglyde® or Monocryl® suture for wound composite outcomes in the first 30 days postpartum (SSI, wound dehiscence, seroma or hematoma). The secondary objectives were to compare the resultant scar and cosmetic effects, overall intraoperative handling, tissue reaction and other adverse events, bacterial accumulation/growth, time taken to resume normal activities, and the post-operative subject satisfaction score in both the groups. On the day of surgery (Visit 1), all routine procedures were followed pre-, peri-, and post-operatively, according to the standard institutional protocol. After completion of the abdominal procedure, either Monoglyde® or Monocryl® suture was used to approximate the abdominal skin. Post-operative follow-up was conducted on Day 3, Day 4-7, Month 1 and Month 4.

本研究为一项前瞻性、单盲、1:1随机分组、多中心双臂临床试验。主要研究目的为对比使用Monoglyde®或Monocryl®缝合线实施皮下皮肤闭合术（subcuticular skin closure）时，产后前30天内的伤口综合结局（包括手术部位感染（Surgical Site Infection，SSI）、伤口裂开、血清肿或血肿）。次要研究目的为对比两组受试者的术后瘢痕与美容效果、整体术中操作性能、组织反应及其他不良事件、细菌定植/增殖情况、恢复正常活动所需时间，以及术后受试者满意度评分。手术当日（访视1），所有受试者均按照机构标准规程完成术前、术中及术后的常规操作流程。腹部手术结束后，使用Monoglyde®或Monocryl®缝合线对腹部皮肤进行对位缝合。术后分别于第3天、第4~7天、第1个月及第4个月开展随访工作。