Efficacy of Triclosan-coated Sutures in the Episiotomy

Episiotomy Clinical Trial

— EPISIOVIC  

Official title:

The Effect of Triclosan-coated Sutures for Reducing Risk of Surgical Site Infection After Episiotomy: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02847936
• Other study ID #: episio1
• Status: Recruiting
• Phase: Phase 4
• First received: July 22, 2016
• Last updated: July 27, 2016
• Start date: July 2016
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: University Tunis El Manar
• Contact: AMIRA AYACHI, Ph D
• Phone: 53660148
• Email: benmrad.amira[@]yahoo.fr
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Episiotomy

Intervention

Procedure:
• vicryl plus suture
episiotomy with triclosan-coated sutures
• vicryl suture
episiotomy with non antibacterial coated suture

Locations

Country	Name	City	State
Tunisia	University Hospital Bougatfa	Bizerte

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

Guo J, Pan LH, Li YX, Yang XD, Li LQ, Zhang CY, Zhong JH. Efficacy of triclosan-coated sutures for reducing risk of surgical site infection in adults: a meta-analysis of randomized clinical trials. J Surg Res. 2016 Mar;201(1):105-17. doi: 10.1016/j.jss.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of sutures used		two hours	No
Primary	number of patients with wound complications (infection, hematoma, disruption)		one week	No
Secondary	cost of the treatment with and without infection	cost of the treatment with and without infection	two weeks	No
Secondary	number of patients with adverse outcomes		two weeks	No