Subcuticular skin closure in Caesarean section polyglactin-910 (Vicaryl Rapid) versus poliglecaprone-25 (Monocryl) – A randomised control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- composite wound complications defined as per CDC guidelines as: surgical site infection (culture-positive SSI), wound haematoma or seroma (defined as at least moderate serous fluid collection or subcutaneous blood collection) or wound dehiscence (wound separation of 1 cm or more in length) within 30 days following LSCS
研究概览
简要总结
Caesarean section contributes to a significant number of deliveries worldwide. The risk of wound complications following CS varies from 3 %- 30%. Several suture materials have been used to aid the physiological wound healing and skin approximation after CS. An ideal skin suture should be safe, lead to good wound healing, have a cosmetically acceptable scar with minimal patient discomfort, and be free from wound complications. Various studies have compared sutures with staplers, different types of absorbable suture materials in subcuticular closure and absorbable with non-absorbable suture materials. We intend to study the composite wound complication rate and the patient satisfaction rate of two different suture materials in subcuticular skin closure. Poliglecaprone 25 (Monocryl, Ethicon) is a routinely used suture for skin closure in our set-up, and we wish to compare the same with the Polyglactin 910 (Vicryl Rapid), which is an easily available, cheap and rapidly absorbable suture material mostly used in skin closure for episiotomy repair.
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 18-40 years
- •undergoing LSCS for various indications in the labour ward of Obstetrics & gynaecology, AIIMS, Bilaspur (H.P.) & IGMC Shimla during the study period.
排除标准
- •booking BMI >30
- •Vertical skin incision
- •Previous vertical abdominal scar
- •Any signs/symptoms suggestive of infection like chorioamnionitis, fever or UTI in the last 2 weeks,
- •Women on systemic steroids/ immune compromised
- •Local skin lesions/ infections
- •Haemodynamically unstable patient
- •Women with GDM/pre-gestation DM on insulin
- •Chronic renal disease, inflammatory bowel disease
- •Preterm LSCS (<36 weeks POG)
- •Anaemia with Hb <9.0 gm%
- •Multiple pregnancy.
结局指标
主要结局
composite wound complications defined as per CDC guidelines as: surgical site infection (culture-positive SSI), wound haematoma or seroma (defined as at least moderate serous fluid collection or subcutaneous blood collection) or wound dehiscence (wound separation of 1 cm or more in length) within 30 days following LSCS
时间窗: within 30 days following LSCS
次要结局
- 1. Post-operative pain: assessed by Visual Analogue Scale (VAS) (12)on day 1 and day 2 post-operative. ((day 1 and day 2 post-op)
- 2. Cosmetic Outcome: assessed by patient satisfaction and observer assessment at 6 weeks post-operative, and the presence of a hypertrophic and hyperpigmented scar anytime till 6 weeks post-operative. (will be assessed by Patient Scar Assessment Scale (PSOAS) and Observer Scar Assessment Scale(6 weeks post-op)
研究者
Dr Harpreet Kaur
Associate Professor, All India Institute of Medical Sciences, Bilaspur, Himachal Pradesh, India