IMPLEMENTATION OF SURGICAL SITE INFECTION PREVENTION BUNDLE IN GYNAECOLOGICAL SURGERIES: A QUALITY CONTROL INITIATIVE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Primary objective: To assess the surgical site infection rates after implementation of bundle in all gynecological surgeries.
研究概览
简要总结
Any surgical procedure carries risk of complications. Surgical Site Infections (SSI) remains a major challenge in clinical practice. The CDC definition4 describes three levels of SSI:
Superficial incisional, Deep incisional, Organ or space infection
A bundled intervention includes all the preoperative, intraoperative and postoperative interventions to avoid SSI. Procedure
All women undergoing gynecologic surgeries through abdominal route for any indication will be included in the study. The women will be divided into the preintervention and intervention group as discussed under heading of sample size calculation. Demographic and clinical details of the women will be recorded as per the proforma. A written and informed consent will be taken from all the women. In the interventional group, after having bath on morning of surgery, routine antibiotic (Injection Ceftriaxone 1g IV) at least 20 minutes before the surgery will be administered. Surgical site of women in intervention group will be prepped with 2% Chlorhexidine-gluconate solution first followed by 70% alcohol and 5% povidone iodine. At the end of the procedure gloves and closing sterile instruments, electrocautery device, suction tip[SR1] will be changed and OT gown of surgeon and nurse, if contaminated. During surgery euglycemia and normothermia will be maintained.
On postoperative day 3, dressing of surgical site will be done with spirit and wound will be examined for any discharge and induration. Patients would be discharged on postoperative day 4 unless otherwise indicated. For Pfannenstiel incision stitches would be removed on postoperative day 8 and midline incisions stitch removal will be done on postoperative day 10. Temperature will be recorded twice a day during hospital stay. Wound cultures for aerobes and anaerobes will be sent in case of wound infections.
Patients who would undergo resuturing or conservative management of wound (as per hospital protocols) will be recorded on proforma. Any readmission within 30 days of discharge will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •All women who underwent abdominal gynecologic surgery will be included.
排除标准
- •Patients who are not operated in GTB hospital or coming with surgical site infection after getting discharge from the hospital will be excluded.
结局指标
主要结局
Primary objective: To assess the surgical site infection rates after implementation of bundle in all gynecological surgeries.
时间窗: 30 days
次要结局
- 1) To assess the rate and causative organisms of superficial, deep incisional and deep organ space surgical site infections rates by microbiological cultures(2) To assess markers for post operative infectious morbidity like fever, duration of surgery, wound dehiscence, etc, resuturing, duration of hospital stay, blood transfusion etc)