Subcuticular Skin Closure at Cesarean Delivery
Comparison of Suture Materials for Subcuticular Skin Closure at Cesarean Delivery
1 other identifier
interventional
220
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Shorter than P25 for not_applicable
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
April 15, 2018
CompletedFirst Submitted
Initial submission to the registry
May 9, 2018
CompletedFirst Posted
Study publicly available on registry
May 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedNovember 16, 2018
October 1, 2018
6 months
May 9, 2018
November 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
surgical site infection
infection
1 week
Study Arms (2)
cesarean section with Vicryl
ACTIVE COMPARATORWomen undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Vicryl.
cesarean section with prolene
ACTIVE COMPARATORWomen undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Prolen.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age 18-40
- women undergoing cesarean section
You may not qualify if:
- body mass index\>30
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kanuni SSTRH
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Berna Aslan A Çetin
KSSTRH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Md, ObGYN
Study Record Dates
First Submitted
May 9, 2018
First Posted
May 25, 2018
Study Start
April 15, 2018
Primary Completion
October 15, 2018
Study Completion
November 1, 2018
Last Updated
November 16, 2018
Record last verified: 2018-10