Suture Versus Glue (Dermabond) Closure During Cesarean Delivery

Adhesive; Band Clinical Trial

— SVGCS  

Official title:

Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02831946
• Other study ID #: 0062-16-MMC
• Status: Recruiting
• Phase: Phase 4
• First received: June 14, 2016
• Last updated: July 11, 2016
• Start date: May 2016
• Est. completion date: February 2018

Study information

• Verified date: July 2016
• Source: Meir Medical Center
• Contact: Yair M Daykan, MD
• Phone: 972-542198231
• Email: yair.dykan[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women between 18 and 45 years

• Elective cesarian section

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive; Band
• Suture; Complications

Intervention

Device:
• MODIFIED VICRYL PLUS
closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture
• DERMABOND GLUE
closing the intra-cuticular layer with Dermabond glue

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba,

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and Observer Scar Assessment Scale (POSAS)	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	2 month	No
Secondary	post operative complication	Development of surgical site infection or wound disruption.	1 month	No