Suture Versus Glue (Dermabond) Closure During Cesarean Delivery

Phase 4

• Conditions: Suture; Complications; Adhesive; Band
• Interventions: Device: DERMABOND GLUE; Device: MODIFIED VICRYL PLUS

• Registration Number: NCT02831946
• Lead Sponsor: Meir Medical Center

Brief Summary

To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.

Detailed Description

Women undergoing planned CS were randomized to either intracutaneous suture closure or glue closure using a 1:1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two months.

Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores 2 months after surgery. Secondary outcome measures were, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption.

Data were analyzed according to the intention to treat principle.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-14
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-11
• Last Update Submitted: 2016-07-11
• Study First Posted: 2016-07-13
• Last Update Posted: 2016-07-13
• Primary Completion: 2017-05
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Pregnant women between 18 and 45 years
• Elective cesarian section

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Exclusion Criteria

• Clinical signs of infection at the time of CS
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DERMABOND GLUE	DERMABOND GLUE	The intra-cuticular layer will closed with with DERMABOND GLUE
MODIFIED VICRYL PLUS	MODIFIED VICRYL PLUS	The intra-cuticular layer will closed with with VICRYL PLUS suture

Primary Outcome Measures

Name	Time	Method
Patient and Observer Scar Assessment Scale (POSAS)	2 month	Subjective scar rating will be performed using the patient component of the POSAS. The POSAS Scale consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale

Secondary Outcome Measures

Name	Time	Method
post operative complication	1 month	Development of surgical site infection or wound disruption.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba,, Israel