Efficacy of Triclosan-coated Sutures in the Episiotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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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

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Episiotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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VICRYL PLUS

triclosan-coated sutures

Group Type ACTIVE_COMPARATOR

vicryl plus suture

Intervention Type PROCEDURE

episiotomy with triclosan-coated sutures

VICRYL

non antibacterial coated sutures

Group Type ACTIVE_COMPARATOR

vicryl suture

Intervention Type PROCEDURE

episiotomy with non antibacterial coated suture

Interventions

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vicryl plus suture

episiotomy with triclosan-coated sutures

Intervention Type PROCEDURE

vicryl suture

episiotomy with non antibacterial coated suture

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No