Efficacy of Triclosan-coated Sutures in the Episiotomy

Study Overview
=================
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.

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

Conditions
-----------------
Episiotomy

Intervention / Treatment
-----------------
* Procedure: vicryl plus suture
* Procedure: vicryl suture


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VICRYL PLUS<br>triclosan-coated sutures | Procedure: vicryl plus suture<br>* episiotomy with triclosan-coated sutures<br>|
| Active Comparator: VICRYL<br>non antibacterial coated sutures | Procedure: vicryl suture<br>* episiotomy with non antibacterial coated suture<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of sutures used |  | two hours | 
| number of patients with wound complications (infection, hematoma, disruption) |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost of the treatment with and without infection | cost of the treatment with and without infection | two weeks | 
| number of patients with adverse outcomes |  | two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
triclosan, sutures, infection