Efficacy of Triclosan-coated Sutures in the Episiotomy
EPISIOVIC
The Effect of Triclosan-coated Sutures for Reducing Risk of Surgical Site Infection After Episiotomy: A Prospective Randomized Controlled Trial
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJuly 28, 2016
July 1, 2016
Same day
July 22, 2016
July 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
number of sutures used
two hours
number of patients with wound complications (infection, hematoma, disruption)
one week
Secondary Outcomes (2)
cost of the treatment with and without infection
two weeks
number of patients with adverse outcomes
two weeks
Study Arms (2)
VICRYL PLUS
ACTIVE COMPARATORtriclosan-coated sutures
VICRYL
ACTIVE COMPARATORnon antibacterial coated sutures
Interventions
Eligibility Criteria
You may qualify if:
- Pregnant women who had had an episiotomy at the delivery
- vaginal delivery
- no further perineal or vaginal lesions present
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Bougatfa
Bizerte, 7000, Tunisia
Related Publications (1)
Guo J, Pan LH, Li YX, Yang XD, Li LQ, Zhang CY, Zhong JH. Efficacy of triclosan-coated sutures for reducing risk of surgical site infection in adults: a meta-analysis of randomized clinical trials. J Surg Res. 2016 Mar;201(1):105-17. doi: 10.1016/j.jss.2015.10.015. Epub 2015 Oct 23.
PMID: 26850191RESULT
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
AMIRA AYACHI, Ph d
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Assistant in Obstetrics and gynecology
Study Record Dates
First Submitted
July 22, 2016
First Posted
July 28, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2016
Study Completion
September 1, 2016
Last Updated
July 28, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share