Comparison between polyglecaparone 25 suture versus skin stapler for skin closure in Cesarean delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Incidence of surgical site infection (SSI), defined according to standard criteria (purulent drainage from incision, culture positive wound drainage, or physician diagnosis of superficial/deep incisional SSI requiring antibiotics or wound opening)
研究概览
简要总结
Cesarean sections are the most frequently performed major surgeries in obstetrics and gynecology. There is increase in number of cesarean sections globally today, and there are several factors that contribute to this including - maternal obesity, an aging maternal population, maternal request for non-medical reasons. These women pass through a period of post operative pain and discomfort. Thus there is a load on the financial resources of healthcare system. Use of the appropriate technique to approximate the wound after caesarean section would not only avoid financial load but also help in early recovery of the patient.
Five to ten times as many surgical-site infections occur after cesarean birth as after vaginal delivery. Thus the question of reducing infections, quick wound healing and better cosmetic outcome have arisen, hence the need for the hour is to identify and make changes to decrease the rate of wound infection and improve cosmetic outcome. An essential part of cesarean section is skin closure; it affects cosmetic outcomes, patient and surgeon satisfaction, and the existence or absence of wound problems. The goals of wound closure include obliteration of dead space, even distribution of tension along deep suture lines, and maintenance of tensile strength across the wound. Methods used for mechanical wound closure includes staples, tape, adhesives, and sutures. Suture closure permits primary wound healing.
The optimal skin closure method should be quick, affordable, safe, and successful. It should also cause the least amount of pain to the patient and provide pleasing esthetic results. In addition, there should be less need for postoperative monitoring and a low incidence of wound complications. The process of wound healing is affected by the structural properties and coating of the suture. Using ideal suture material for subcuticular skin closure not only aids in restoring skin functions but also provides cosmesis. Subcuticular suturing is performed just beneath the epidermal layer and is preferred for postcesarean skin approximation as it prevents foreign material from passing through. Subcuticular skin suturing following CS has a reduced incidence of wound issues and aesthetically pleasing outcomes. Poliglecaprone is an absorbable suture, completely absorbed within 90 days of application, with minimal inflammatory reaction. Therefore, this study is designed to compare sub-cuticular skin closure by monoglyde versus skin stapler
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women aged 18–45 years undergoing LSCS (elective or emergency) Skin closure planned with single layer subcuticular technique Able and willing to provide written informed consent and attend follow-up visits.
排除标准
- •Known allergy to suture or staple material Current systemic infection or immunosuppression (e.g., long-term steroids, chemotherapy) Known bleeding disorder Significant obesity where fascial closure or wound management is expected to differ (BMI greater than 40 kg/m²) Multi-layer disrupted closure or major intraoperative complication requiring re-exploration Previous lower abdominal surgery with distorted anatomy at incision site.
结局指标
主要结局
Incidence of surgical site infection (SSI), defined according to standard criteria (purulent drainage from incision, culture positive wound drainage, or physician diagnosis of superficial/deep incisional SSI requiring antibiotics or wound opening)
时间窗: Incidence of SSI within 30 days post operation.
次要结局
- Cosmetic outcome of the scar measured by a validated scale — e.g., Patient and Observer Scar Assessment Scale (POSAS)(Day of discharge, 30 days post operation and 3 months post operation)
- Wound-related complications: seroma, hematoma, wound dehiscence/separation (partial/full), suture extrusion, hypertrophic scar/keloid formation(Within 3 months of post operation)
- Postoperative pain at incision site (measured by Visual Analogue Scale)(24 hours post operation, 7 days post operation and 30 days post operation)
- Time taken for skin closure during Cesarean section(Day of surgery)
- Re-admission related to wound complications(within 30 days post operation)
- Patient satisfaction with wound healing (Likert scale)(3 months post operatively)
研究者
Mahendra G
Adichunchanagiri Institute of Medical Sciences
