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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT02847936 |
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Date of registration:
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22/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Triclosan-coated Sutures in the Episiotomy
EPISIOVIC |
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Scientific title:
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The Effect of Triclosan-coated Sutures for Reducing Risk of Surgical Site Infection After Episiotomy: A Prospective Randomized Controlled Trial |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02847936 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Tunisia
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Contacts
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Name:
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AMIRA AYACHI, Ph D |
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Address:
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Telephone:
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53660148 |
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Email:
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benmrad.amira@yahoo.fr |
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Affiliation:
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Name:
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AMIRA AYACHI, Ph D |
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Address:
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Telephone:
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53660148 |
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Email:
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benmrad.amira@yahoo.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Episiotomy
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Intervention(s)
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Procedure: vicryl plus suture
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Procedure: vicryl suture
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Primary Outcome(s)
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number of sutures used
[Time Frame: two hours]
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number of patients with wound complications (infection, hematoma, disruption)
[Time Frame: one week]
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Secondary Outcome(s)
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number of patients with adverse outcomes
[Time Frame: two weeks]
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cost of the treatment with and without infection
[Time Frame: two weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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