NCT07483411

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jan 2025Aug 2027

Study Start

First participant enrolled

January 27, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 16, 2026

Last Update Submit

March 28, 2026

Conditions

Surgical Site Infection (SSI)

Keywords

cesarean sectionbiological adhesiveintracuticular sutureObstetrics surgical site infection

Outcome Measures

Primary Outcomes (1)

  • Skin wound complecations

    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 Outcomes (3)

  • Recovery and connivance of the patient at POD 2

    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

    6-8 weeks post surgery

  • Scar appearance after 6-8 weeks

    6-8 weeks post surgery

Study Arms (2)

Skin closure using intracuticular suture alone

NO INTERVENTION

this group will undergo skin closure at the end of the cesarean section using intracuticular suture alone using monofilament suture.

Skin closure using intracuticular suture and biological adhesive material in addition

EXPERIMENTAL

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

Interventions

DermabondOTHER

The intervention is the addition of skin adhesive biological material on top of an intracuticular suture in skin closure after cesarean section

Also known as: skin adhesive material
Skin closure using intracuticular suture and biological adhesive material in addition

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Medical Center, Ein Karem Campus

Jerusalem, 9112001, Israel

RECRUITING

Related Publications (7)

  • Carriere ME, Mokkink LB, Tyack Z, Westerman MJ, Pijpe A, Pleat J, van de Kar AL, Brown J, de Vet HCW, van Zuijlen PPM. Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study. Qual Life Res. 2023 Feb;32(2):583-592. doi: 10.1007/s11136-022-03244-6. Epub 2022 Nov 10.

    PMID: 36355319BACKGROUND

  • Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.

    PMID: 8537427BACKGROUND

  • Feese CA, Johnson S, Jones E, Lambers DS. A randomized trial comparing metallic and absorbable staples for closure of a Pfannenstiel incision for cesarean delivery. Am J Obstet Gynecol. 2013 Dec;209(6):556.e1-5. doi: 10.1016/j.ajog.2013.08.001. Epub 2013 Aug 3.

    PMID: 23921089BACKGROUND

  • Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.

    PMID: 20417924BACKGROUND

  • Mackeen AD, Khalifeh A, Fleisher J, Vogell A, Han C, Sendecki J, Pettker C, Leiby BE, Baxter JK, Sfakianaki A, Berghella V. Suture compared with staple skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1169-1175. doi: 10.1097/AOG.0000000000000227.

    PMID: 24807325BACKGROUND

  • de Graaf IM, Oude Rengerink K, Wiersma IC, Donker ME, Mol BW, Pajkrt E. Techniques for wound closure at caesarean section: a randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):47-52. doi: 10.1016/j.ejogrb.2012.07.019. Epub 2012 Aug 19.

    PMID: 22910336BACKGROUND

  • Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671.

    PMID: 34130991BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Efrat Shekel, MD

CONTACT

+972507680404efratsh14@gmail.com

Doron Kabiri, MD, MPH

CONTACT

+972508946898doronkabiri@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
maternal-fetal medicine specialist at hadassah university medical center

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 19, 2026

Study Start

January 27, 2025

Primary Completion (Estimated)

January 27, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All IPD included in the statistical analysis will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The IPD will be available from January 2027
Access Criteria
people interested in the IPD will be able to access it upon request

Locations

IL(1)