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NCT Number: NCT07483411

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah University Medical Center, Ein Karem Campus

Jerusalem, 9112001, Israel

Location status: Recruiting

Location contact

Efrat Shekel, MD

CONTACT

[email protected]

+972507680404

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermabond

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Doron Kabiri, MD, MPH

CONTACT

[email protected]

+972508946898

Efrat Shekel, MD

CONTACT

[email protected]

+972507680404

Sponsors and collaborators

Lead sponsor

Doron Kabiri

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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