Subcuticular Skin Closure at Cesarean Delivery

NCT ID: NCT03536832

Last Updated: 2018-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2018-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cesarean Section; Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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cesarean section with Vicryl

Women undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Vicryl.

Group Type ACTIVE_COMPARATOR

Cesarean Section with Vicryl

Intervention Type PROCEDURE

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 prolene

Women undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Prolen.

Group Type ACTIVE_COMPARATOR

Cesarean Section with Prolen

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18-40
* women undergoing cesarean section

Exclusion Criteria

* body mass index\>30
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Berna Aslan Cetin

Md, ObGYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berna Aslan A Çetin

Role: PRINCIPAL_INVESTIGATOR

KSSTRH

Locations

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Kanuni SSTRH

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018.4.20

Identifier Type: -

Identifier Source: org_study_id

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