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临床试验/NCT03983343
NCT03983343招募中不适用

Skin Glues Compared to Running Sutures for Perineal Skin Repair After Vaginal Delivery. A Randomized Controlled Trial

HaEmek Medical Center, Israel2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
182
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

The incidence of a perineal tears during labor is 70 to 90%, while in 96% of the cases it's a minor perineal tear (grade 1). In about 3% to 4% the perineal tear is major and involve the external (grade 3) and the internal anal sphincter (grade 4). Episiotomy, which is considered an iatrogenic grade 2 tear, is performed in about 12% of vaginal deliveries.

Complications related to perineal tears include bleeding, the most common, that may lead to the development of vaginal or perineal hematoma. Additionally, local infection can develop and complicate the recovery from the injury. In rare cases, abscesses may occur and in rarer cases necrotizing fasciitis or recto-vaginal fistula may also evolve.

The "gold standard" method for repairing perineal tears is to use absorbable (preferably fast-absorbing) sutures. Grade 1 tears that do not bleed and do not disrupt the anatomical structure of the perineum usually do not require repair. Grade 2 tears are usually sewn in a continuous absorbent suture and less in the form of single stitches.

The use of adhesive glue to repair skin injuries began 20 years ago and the main adhesive used is dermabond® (Ethicon Inc. octyl-2-cyanoacrylate). The use of glue is faster and lead to less pain than the use of stitches or staples. It can be used for a variety of large or small, traumatic or iatrogenic wounds, with a cosmetic result, infection rate, and dehiscence rate similar to those achieved by stitches or staples.

In light of this, the investigators intend to conduct a randomized trial that will examine the advantages and disadvantages of the use of glue compared to the traditional sutures for closure of the skin in perineal tears grade 1 and 2 and episiotomies after vaginal delivery.

The investigators hypothesis is that the use of adhesive glue to close the skin in perineal tears grade 1 and 2 (including episiotomy), will be faster and associated with less pain compared to the traditional suturing method, without a significant difference in the rate of complications.

详细描述

Trial design: Randomized controlled trial.

Objectives: To examine the effect of adhesive glue compared to fast-absorbable running sutures on pain sensation following repairing perineal skin in cases of tears grade 1 and 2.

Trial population: Women delivering vaginally at Emek Medical Center, and experience a spontaneous perineal tear, grade 1 or 2, or episiotomy.

Trial course:

Eligible patients will be asked to participate in this trial before perineal tear repair. Following providing an explanation about the trial, patients will be asked to provide written informed consent to participate in the trial.

研究设计

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

盲法说明

Cosmetic result will be assessed 4-6 weeks after the repair by a doctor who did not participate in tear suturing immediately after delivery, and is not aware to the repair method used.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-
  • Term birth (> 37.0 weeks).
  • Perineal tears grade 1 or 2, or episiotomy.

排除标准

  • Perineal tears grades 3 or
  • Operative vaginal deliveries.
  • Significant background diseases that can affect pain or recovery time: Pregestational diabetes mellitus, any heart disease, severe pulmonary disease, collagen or connective tissue disease, rheumatic diseases, autoimmune diseases, known immunodeficiency and chronic steroid use.
  • Signs of local infection prior to the beginning of repair of the tear.
  • Known allergy to exofin®.
  • Pregestational body mass index > 35 kg/m
  • Women with excessive bleeding that does not allow the use of glue.
  • Delivery of a dead fetus.

结局指标

主要结局

Pain intensity

时间窗: within 2 hours after completing the procedure

Pain intensity will be measured by asking the woman to describe the pain related to the procedure using a 0 (no pain) to 100 VAS (intolerable pain)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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