Efficacy of Triclosan-coated Sutures in the Episiotomy

Phase 4

• Conditions: Episiotomy
• Interventions: Procedure: vicryl plus suture; Procedure: vicryl suture

• Registration Number: NCT02847936
• Lead Sponsor: University Tunis El Manar

Brief Summary

Surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. The aim of this study was to compare the surgical site infection with triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after delivery.

Detailed Description

Women undergoing planned were randomized to either episiotomy suture with VICRYL PLUS or VICRYL. The primary outcome measures were number of sutures used and the development of hematoma, seroma, surgical site infection (SSI) or wound disruption one week after episiotomy. Secondary outcome measures were the cost of the treatment with or without infection, and scar evaluation (wound complication).

Data were analyzed according to the intention to treat principle.

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Primary Completion: 2016-07
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-27
• Last Update Submitted: 2016-07-27
• Study First Posted: 2016-07-28
• Last Update Posted: 2016-07-28
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Pregnant women who had had an episiotomy at the delivery
• vaginal delivery
• no further perineal or vaginal lesions present

Exclusion Criteria

• collagen disease
• known immunodeficiency
• Clinical signs of infection at the time of episiotomy
• History of keloids and a medical disorder that could affect wound healing
• Hypersensitivity to any of the suture materials used in the protocol
• Diabetes mellitus
• Disorders requiring chronic corticosteroid use or immunosuppression
• Instrumental extraction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VICRYL PLUS	vicryl plus suture	triclosan-coated sutures
VICRYL	vicryl suture	non antibacterial coated sutures

Primary Outcome Measures

Name	Time	Method
number of sutures used	two hours
number of patients with wound complications (infection, hematoma, disruption)	one week

Secondary Outcome Measures

Name	Time	Method
cost of the treatment with and without infection	two weeks	cost of the treatment with and without infection
number of patients with adverse outcomes	two weeks

Trial Locations

Locations (1)

University Hospital Bougatfa; 🇹🇳 Bizerte, Tunisia