Efficacy of Triclosan-coated Sutures in the Episiotomy (EPISIOVIC)

University Tunis El Manar

Status and phase: Unknown; Phase 4

Conditions: Episiotomy

Treatments: Procedure: vicryl suture; Procedure: vicryl plus suture

Study type: Interventional

Funder types: Other

Identifiers

NCT02847936

episio1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

400 participants in 2 patient groups

VICRYL PLUS

Active Comparator group

Description:

triclosan-coated sutures

Treatment:

Procedure: vicryl plus suture

VICRYL

Active Comparator group

Description:

non antibacterial coated sutures

Treatment:

Procedure: vicryl suture