Clinical Trials Directory

Trials / Unknown

UnknownNCT02847936

Efficacy of Triclosan-coated Sutures in the Episiotomy

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
400 (estimated)
Sponsor
University Tunis El Manar · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREvicryl plus sutureepisiotomy with triclosan-coated sutures
PROCEDUREvicryl sutureepisiotomy with non antibacterial coated suture

Timeline

Start date
2016-07-01
Primary completion
2016-07-01
Completion
2016-09-01
First posted
2016-07-28
Last updated
2016-07-28

Locations

1 site across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT02847936. Inclusion in this directory is not an endorsement.