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

U

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

Trial contacts and locations

1

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Central trial contact

AMIRA AYACHI, Ph d; AMIRA AYACHI, Ph D

Data sourced from clinicaltrials.gov

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