Skin Adhesive Plus Intra-cuticular Suture Versus Suture Alone for Cesarean Skin Closure

March 28, 2026 updated by: Doron Kabiri

Intracuticular Suture Alone Compared to Intracuticular Suture and Skin Adhesive Material for Skin Closure After Cesarean Delivery : a Prospective Randomized Control Study

The goal of this randomized control trial is to compare two skin closure techniques after cesarean section. Both techniques are currently in wide use but no comparison between the two was reasserted yet. The two techniques are- First technique is intracuticular suture using monofilament suture, Second technique is intracuticular suture and biological adhesive material. The investigators' primary outcome is to explore the rate of skin scar complications to understand whether one technique has a lower complication rate then the other. The secondary outcomes is to check whether one technique is better then the other in terms of patients' satisfaction, convenience and scar healing and appearance.

Patients at the age of 18 and above, undergoing elective cesarean section at the Hadassa medical center, can participate.

participants will be randomly assigned to one of the groups- the firs or the second technique.

Patients will be asked to fill out a questionnaire on POD 2 and attend a check-up appointment in-person with their surgeon 6-8 weeks post surgery. at the check-up the patient will be asked to fill out another questionnaire and undergo a scar appearance evaluation by the surgeon.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah University Medical Center, Ein Karem Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergoing elective cesarean section at Hadassa medical center
  • Patients undergoing elective cesarean section btween 37+0/7 and 41+6/7 weeks of gestation

Exclusion Criteria:

  • Patients undergoing emergency cesarean section
  • patients undergoing cesarean section before 37+0/7 weeks of gestation
  • patients with a history of previous wound complications after previous Caesarean section

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Skin closure using intracuticular suture alone
this group will undergo skin closure at the end of the cesarean section using intracuticular suture alone using monofilament suture.
Experimental: Skin closure using intracuticular suture and biological adhesive material in addition
this group will undergo skin closure at the end of the cesarean section using intracuticular suture using monofilament suture and biological adhesive material in addition.
Other: Dermabond
The intervention is the addition of skin adhesive biological material on top of an intracuticular suture in skin closure after cesarean section
Other Names:
  • skin adhesive material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin wound complecations
Time Frame: From the surgery and up to 8 weeks post surgery
Any skin complications including superficial infection, deep infection, seroma, skin open, the need for antibiotics and skin related complaints including rash, itching, discharge.
From the surgery and up to 8 weeks post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery and connivance of the patient at POD 2
Time Frame: From the day of the surgery up to 8 weeks post surgery
The investigators will assess the satisfaction of the patient on POD 2 using a Likert score based questionnaire designed for the study. Each question is graded between 0-10, the summery of all questions is the grade of the questionnaire
From the day of the surgery up to 8 weeks post surgery
Patients' satisfaction from their recovery and scar healing process 6-8 weeks post surgery
Time Frame: 6-8 weeks post surgery
The investigators will assess the satisfaction of the patient 6-8 weeks post the surgery using the POSAS 3.0 (patient & observer scar assessment scale)- the patient questionnaire for generic scar. the score for this questionnaire rages between 16 to 80, the lower the score, the better scar outcomes
6-8 weeks post surgery
Scar appearance after 6-8 weeks
Time Frame: 6-8 weeks post surgery
The investigators will assess the scar healing and appearance using the Vancouver Scar Scale 6-8 weeks post surgery. the assessment will be made by the surgeon, in person. The grade for this questionnaire ranges between 0 and 13, the lower the score, the better outcome.
6-8 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Doron Kabiri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2025

Primary Completion (Estimated)

January 27, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMO041524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD included in the statistical analysis will be shared

IPD Sharing Time Frame

The IPD will be available from January 2027

IPD Sharing Access Criteria

people interested in the IPD will be able to access it upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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