跳至主要内容
临床试验/CTRI/2024/09/073911
CTRI/2024/09/073911尚未招募不适用

Outcomes of Episiotomy suturing using Chromic Catgut, Polyglactin 910,Polyglactin 910 Rapide sutures- A Triple – arm, Concurrent parallel Randomised Controlled Trial.

AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年9月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
To compare the effectiveness of three absorbable suture materials - Chromic Catgut, Polyglactin 910,Polyglactin 910 Rapide sutures in terms of postoperative outcomes

研究概览

简要总结

After getting IEC clearance from the institute and CTRI registration, informed and written consent from the patient who are willing to get enrolled in the study. Patients undergoing vaginal deliveries will be taken up for study based on inclusion and exclusion criteria. Patients having vaginal delivery with mediolateral episiotomy will be randomly allocated into 3 groups. Block randomization sequential allocation into blocks. Random sequence generation by random table prior to start of study. Group A (CHROMIC CATGUT), Group B (POLYGLACTIN 910), Group C (POLYGLACTIN 910 RAPIDE). All patients are sutured by same technique and by the same person. Same postoperative antibiotic and analgesic were given to all patients. Postoperative outcomes such as pain, healing, scarring/dyspareunia followed up on Day1,Day 2, Day 3,2nd week,4th week and 3 months postnatally.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • ALL VAGINAL DELIVERIES UNDERGOING EPISIOTOMY.

排除标准

  • INFECTION (CHORIOAMNIONITIS).

结局指标

主要结局

To compare the effectiveness of three absorbable suture materials - Chromic Catgut, Polyglactin 910,Polyglactin 910 Rapide sutures in terms of postoperative outcomes

时间窗: Day 1,Day 2,Day 3,2ND week,4TH week,3 months postnatally

次要结局

  • POSTOPERATIVE PAIN,WOUND HEALING,SCARRING/FIBROSIS(DAY1,DAY2,DAY3,2ND WEEK,4TH WEEK,3MONTHS POSTNATALLY)

研究者

发起方
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

NANDINI S

AARUPADAI VEEDU MEDICAL COLLEGE,PONDICHERRY

研究点 (1)

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