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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02847936

Acronym

EPISIOVIC

Enrollment

400

Registered

2016-07-28

Start date

2016-07-31

Completion date

2016-09-30

Last updated

2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episiotomy

Keywords

triclosan, sutures, infection

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.

Interventions

PROCEDUREvicryl plus suture

episiotomy with triclosan-coated sutures

PROCEDUREvicryl suture

episiotomy with non antibacterial coated suture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

Tunisia

Contacts

Primary ContactAMIRA AYACHI, Ph D

benmrad.amira@yahoo.fr53660148

Backup ContactAMIRA AYACHI, Ph d

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026