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NCT03536832 Clinical Trial

Subcuticular Skin Closure at Cesarean Delivery

Cesarean Section; Infection Clinical Trial

Official title:
Comparison of Suture Materials for Subcuticular Skin Closure at Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03536832
Other study ID # 2018.4.20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date November 1, 2018

Study information
Verified date October 2018
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date November 1, 2018
Est. primary completion date October 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Age 18-40

- women undergoing cesarean section

Exclusion Criteria:

- body mass index>30

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cesarean Section 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 Vicryl.
• Cesarean Section with 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.

Locations
Country Name City State
Turkey Kanuni SSTRH Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary surgical site infection infection 1 week
See also
  Status Clinical Trial Phase
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Completed NCT05330650 - Evaluation of Triclosan Coated Suture in Obstetrical Surgery Phase 4
Completed NCT04365452 - The Invia Motion at Cesarean Study Phase 4
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Completed NCT03284749 - Effect of Copper on the Healing of Obstetric Wounds N/A
Active, not recruiting NCT06048692 - Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections Phase 3
Completed NCT06119113 - Wound Infection Due to Suture Material in Caesarean Skin Incision and Evaluation of Cosmetic Results N/A
Terminated NCT03479931 - Caesarean Delivery With or Without an Indwelling Bladder Catheter. A Randomised Trial. N/A
Recruiting NCT04476212 - Prophylaxis of Surgical Wound Infection With Topical Antibiotics N/A