- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536832
Subcuticular Skin Closure at Cesarean Delivery
November 14, 2018 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
Comparison of Suture Materials for Subcuticular Skin Closure at Cesarean Delivery
Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure.
However, the optimal choice of suture material for subcuticular skin closure is unclear.
Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section.
Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cesarean section is the most common abdominal surgery worldwide.
Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure.
However, the optimal choice of suture material for subcuticular skin closure is unclear.
Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section.
Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.
Study Type
Interventional
Enrollment (Actual)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Kanuni SSTRH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age 18-40
- women undergoing cesarean section
Exclusion Criteria:
- body mass index>30
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: cesarean section with Vicryl
Women undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Vicryl.
|
Pfnannenstiel incision will be done under general or spinal anaesthesia.
The abdomen will be opened and fetus and plasenta will be delivered.
Then abdomen will be closed.
Skin will be closed with Vicryl.
|
Active Comparator: cesarean section with prolene
Women undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Prolen.
|
Pfnannenstiel incision will be done under general or spinal anaesthesia.
The abdomen will be opened and fetus and plasenta will be delivered.
Then abdomen will be closed.
Skin will be closed with prolen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
surgical site infection
Time Frame: 1 week
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infection
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Berna Aslan A Çetin, KSSTRH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2018
Primary Completion (Actual)
October 15, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
May 9, 2018
First Submitted That Met QC Criteria
May 23, 2018
First Posted (Actual)
May 25, 2018
Study Record Updates
Last Update Posted (Actual)
November 16, 2018
Last Update Submitted That Met QC Criteria
November 14, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2018.4.20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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