- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02847936
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: AMIRA AYACHI, Ph D
- Phone Number: 00216 53660148
- Email: benmrad.amira@yahoo.fr
Study Contact Backup
- Name: AMIRA AYACHI, Ph d
Study Locations
-
-
-
Bizerte, Tunisia, 7000
- Recruiting
- University Hospital Bougatfa
-
Contact:
- AMIRA AYACHI, Ph D
- Phone Number: 00216 53660148
- Email: benmrad.amira@yahoo.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: VICRYL PLUS
triclosan-coated sutures
|
episiotomy with triclosan-coated sutures
|
Active Comparator: VICRYL
non antibacterial coated sutures
|
episiotomy with non antibacterial coated suture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of sutures used
Time Frame: two hours
|
two hours
|
number of patients with wound complications (infection, hematoma, disruption)
Time Frame: one week
|
one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cost of the treatment with and without infection
Time Frame: two weeks
|
cost of the treatment with and without infection
|
two weeks
|
number of patients with adverse outcomes
Time Frame: two weeks
|
two weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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