AzTrials
AzTrials

Surgical Site Infection (SSI)NCT07483411

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

A study testing Dermabond in people with Surgical Site Infection (SSI), run by Doron Kabiri at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Surgical Site Infection (SSI)
What is being tested?
Dermabond
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteIsrael
Study dates
27 Jan 2025to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Efrat Shekel, MD contact

+972507680404

efratsh14@gmail.com

Doron Kabiri, MD, MPH contact

+972508946898

doronkabiri@gmail.com

Israel1 site, 1 recruiting

  • Hadassah University Medical Center, Ein Karem Campus

    Jerusalem, 9112001

    Efrat Shekel, MD, +972507680404, efratsh14@gmail.com

    Recruiting

Other trials in Israel

About this study

Official title: 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.

Read more

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.

Being tested
Dermabond
Keywords
cesarean section, biological adhesive, intracuticular suture, Obstetrics surgical site infection
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DermabondOther

    Also called skin adhesive material

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

Study groups in NCT07483411
Study groupRoleWhat they receive
Skin closure using intracuticular suture aloneNo interventionthis 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 additionExperimentalthis group will undergo skin closure at the end of the cesarean section using intracuticular suture using monofilament suture and biological adhesive material in addition.
Receives: Other: Dermabond

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From the surgery and up to 8 weeks post surgery

Secondary outcomes (3)

  1. Recovery and connivance of the patient at POD 2

    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

    Measured: From the day of the surgery up to 8 weeks post surgery

  2. Patients' satisfaction from their recovery and scar healing process 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

    Measured: 6-8 weeks post surgery

  3. Scar appearance after 6-8 weeks

    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.

    Measured: 6-8 weeks post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start27 Jan 2025
  3. Primary completion27 Jan 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483411
Sponsor's protocol ID
HMO041524
Status last verified
Mar 2026
First submitted
16 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD included in the statistical analysis will be shared

Publications

  • 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.

    PubMed 36355319

  • 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.

    PubMed 8537427

  • 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.

    PubMed 23921089

  • 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.

    PubMed 20417924

  • 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.

    PubMed 24807325

  • 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.

    PubMed 22910336

  • 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.

    PubMed 34130991

Questions about this trial

What is this clinical trial studying?

A study testing Dermabond in people with Surgical Site Infection (SSI), run by Doron Kabiri at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Efrat Shekel, MD (+972507680404, efratsh14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin wound complecations (time frame: From the surgery and up to 8 weeks post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07483411, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in