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临床试验/NCT04177381
NCT04177381已完成不适用

Comparative Study Between Subcutaneous Tissue Closure Versus Drain in Obese Women Undergo Elective Cesarean Section Arandomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2021年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
352
试验地点
1
主要终点
wound infection

研究概览

简要总结

Randomised cinical trial in Kasr Alainy Hospital.352 obese women pregnant with gestational age >38 wk ,theire age range from (25-35) years and BMI between (30 -40) undergoing elective cesarean section were randomised into 4 groups and compare the role of subcutaneous tissue closure in post cesarean section wound complications.

groups are: 4 groups each group was 86 women : A -interrupted closure of subcutaneous tissue with drain ( a closed nonvacuum drain was inserted in the tissue and exite from the skin through a separate opening and stitch to the skin) .

B-interrupted closure of subcutaneous tissue without drain. c- non closure of subcutaneous tissue with drain only. d- non closure of subcutaneous tissue without drain.

All womenu nder going CS with Pfannenstiel incision were considered to be eligible if time allowed informed consent before the surgery

详细描述

Randomised cinical trial in Kasr Alainy Hospital.352 obese women pregnant with gestational age >38 wk ,their age range from (25-35) years and BMI between (30 -40) undergoing elective cesarean section were randomised into 3 groups (100 patients in each group)and compare the role of subcutaneous tissue closure in post cesarean section wound complications.

4 groups are:: A -interrupted closure of subcutaneous tissue with drain ( a closed nonvacuum drain was inserted in the tissue and exit from the skin through a separate opening and stitch to the skin) .

B-interrupted closure of subcutaneous tissue without drain. c- non closure of subcutaneous tissue with drain only. d- non closure of subcutaneous tissue without drain.

All women under going CS with Pfannenstiel incision were considered to be eligible if time allowed informed consent before the surgery All surgical procedures were performed by obstetric and gynecology residents under the supervision of attending physicians After the sequential closure of the uterus and peritoneum, the fascia was closed with 2-0 polyglactin 910 (Vicryl). The depth of the subcutaneous adipose tissue was measured with a sterile ruler from the fascia to the skin edge at the middle of the superior aspect of the skin incision.Women with a subcutaneous tissue thickness of 4.0 cm or more were then formally enrolled and randomized to one of the two subcutaneous closure techniques. Subcutaneous hemostasis were achieved using electrocautery and skin was approximated with subcuticular suture using 2-0 polyglactin910 (VicrylRapide).company city country In the drain group, a closed nonvacuum drain was inserted in the tissue and exite from the skin through a separate opening and stitch to the skin (Al Allair 2000). company city country The drain was left until the drainage rate was less than 30 ml/day or after 72h .( The skin was closed with a continuous nonabsorbable polypropylene 2/0 (Acufirm; Ernst Kratz, Germany) subcuticular sutures. Operative time was estimated from the start of skin incision until the end of skin suturing. The drain was left until the drainage rate was less than 50 ml/day.

All randomized women received standard postoperative wound care. Surgical dressing was removed on the first postoperative and all participants were discharged 24 h after the CS. The participants were invited to two follow-up in the first and second week post operative with regard to postoperative pain, postoperative fever, hospital stay duration, wound infection, wound seroma, wound disruption, and the need for redressing. The postoperative pain was judged after 24 h using visual analogue scale, in addition any time clinically indicated. Patients and physicians who assessed the incision postoperatively were blinded towards the study group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •obese women who BMI(30- 40 kg/m2)
  • •Gestational age (37-41) week calculated by sure dates and confirmed by first trimester US,
  • •single fetus.
  • •Elective lower segment cesarean section

排除标准

  • •Any medical disorders affect wound healing as:
  • •Diabetes mellitus.
  • •On steroids.
  • •Immunedeficiency.
  • •Hypoalbuminemia.
  • •Skin infections or history of wound infections.
  • •Multifetal pregnancy.
  • •Obstetric complications eg.placenta previa.
  • •Intraoperative complications as intestinal injury or bladder injury

研究组 & 干预措施

interrupted closure of subcutaneous tissue without dra

Active Comparator

consist of 88 patients that will be allocated for interrupted closure of subcutaneous tissue without drain

干预措施: Cesarean section (Procedure)

interrupted closure of subcutaneous tissue without dra

Active Comparator

consist of 88 patients that will be allocated for interrupted closure of subcutaneous tissue without drain

干预措施: subcutanous sutures (Procedure)

interrupted closure of subcutaneous tissue with drain

Active Comparator

consist of 89 patients that will be allocated for interrupted closure of subcutaneous tissue with drain

干预措施: Cesarean section (Procedure)

interrupted closure of subcutaneous tissue with drain

Active Comparator

consist of 89 patients that will be allocated for interrupted closure of subcutaneous tissue with drain

干预措施: subcutanous sutures (Procedure)

interrupted closure of subcutaneous tissue with drain

Active Comparator

consist of 89 patients that will be allocated for interrupted closure of subcutaneous tissue with drain

干预措施: subcutanous drain (Device)

non closure of subcutaneous tissue with drain

Active Comparator

In the drain group,a closed non vacuum drain will be inserted in the tissue and exit from the skin through a separate opening and stitch to the skin

干预措施: Cesarean section (Procedure)

non closure of subcutaneous tissue with drain

Active Comparator

In the drain group,a closed non vacuum drain will be inserted in the tissue and exit from the skin through a separate opening and stitch to the skin

干预措施: subcutanous drain (Device)

non closure of subcutaneous tissue and no drain

Active Comparator

87 women without subcutanous sutures and without drain

干预措施: Cesarean section (Procedure)

结局指标

主要结局

wound infection

时间窗: 2-8 weeks after the operation

subjective evaluation of wound redness, seroma and induration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed M Maged, MD

professor

Cairo University

研究点 (1)

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