跳至主要内容
临床试验/CTRI/2020/12/029925
CTRI/2020/12/029925已完成Unknown

Single blind, randomized comparative study assessing clinical equivalence of two polyglactin 910 fast absorbing suture brands, Trusynth Fast® and Vicryl Rapide®, on maternal morbidity experienced by women following episiotomy repair

Healthium Medtech Pvt Ltd2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月1日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
1. Subjective assessment of perineal pain post episiotomy repair, with Trusynth Fast® and Vicryl Rapide®

研究概览

简要总结

Episiotomy is a surgical incision of the perineum (the area between the vaginal opening and back passage) to enlarge the vaginal opening during labor or delivery.  This procedure is done with scissors or scalpel and requires repair by suturing. Polyglactin 910 fast-absorbing sutures are commonly used for episiotomy repair as it is associated with less perineal pain, analgesic use, infection and re-suturing. In this study, we plan to assess differences in maternal morbidity between two commonly used brands of polyglactin 910 fast-absorbing sutures, Trusynth Fast® and Vicryl rapide®.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant Blinded

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, with a singleton pregnancy
  • Primiparous or multiparous women who will require episiotomy during the course of vaginal delivery
  • Women with gestational age of >34 weeks
  • Women with good systemic/ mental health as per opinion of investigator
  • Women who have given informed consent.

排除标准

  • Women with intrapartum fever and history of bleeding/coagulation disorders
  • Women having perineal tears, cervical tears, vaginal tears, extension of the episiotomies
  • Women who had a previous perineal surgery other than the primary repair after child birth
  • Women with known HIV or the hepatitis B infection
  • Women who has delivered a dead fetus
  • Women having any known allergy to the suture materials
  • Women already participating in another trial
  • Women unlikely to comply with study procedure or complete the scheduled follow up visit, in the opinion of investigator
  • Other indication-based exclusion, in the opinion of investigator.

结局指标

主要结局

1. Subjective assessment of perineal pain post episiotomy repair, with Trusynth Fast® and Vicryl Rapide®

时间窗: Day 2, Day 11, Week 6 and Week 12

次要结局

  • 1. To compare the use of analgesics in both the groups(2. To evaluate the wound healing in both the groups)

研究者

发起方
Healthium Medtech Pvt Ltd
申办方类型
Pharmaceutical industry-Indian

研究点 (2)

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