Cesarean SectionNCT05903547
A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study
A study testing Dermabond Prineo and Suture in people with Cesarean Section and Complication, run by Columbia University at 1 site in United States.
Trial summary
The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Complication, Wound
- What is being tested?
- Dermabond Prineo and Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 5 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age 18 years or older
- All women scheduled for primary or repeat cesarean deliveries
- All women undergoing intrapartum or antepartum cesarean delivery
- Pfannenstiel skin incision
- Birth of a live infant at time of cesarean delivery
Who cannot join
- Vertical skin incision
- Cesarean hysterectomy
- Emergency or stat cesarean delivery excluding standard preoperative preparation measures (i.e., use of Chlorhexidine skin prep, vaginal prep, etc)
- Intrapartum stillbirth
- Planned postpartum follow up at another facility
- Contraindications to routine postpartum pain medications
- Adhesive or tape allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center/NYP
New York, New York, 10032
About this study
Official title: Glue Versus Subcuticular Suture for Cesarean Closure: a Randomized Control Trial
The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.
Read the detailed description
The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.
- Conditions
- Cesarean Section, Complication, Wound
- Being tested
- Dermabond Prineo, Suture
- Keywords
- Complications, Wound, Hematoma, Surgical Incision
- Medical subject headings
- Wounds and Injuries, Hematoma, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabond PrineoDevice
For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
SutureOther
For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
| Study group | Role | What they receive |
|---|---|---|
| Dermabond Prineo Group | Active comparator | At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system. Receives: Device: Dermabond Prineo |
| Suture Group | Placebo comparator | At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture. Receives: Other: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Scar Satisfaction Scale Score
The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction.
Measured: Assessed at 6-weeks postpartum
Secondary outcomes (3)
Incidence of Surgical Site Infection (SSI)
A composite of surgical site infection (SSI) will be assessed. This composite will include superficial and deep SSI, endometritis, wound separation from any cause, and/or fascial dehiscence.
Measured: Assessed during delivery hospitalization and at 6-week follow-up
Skin Closure Time
The skin closure time will be assessed.
Measured: Intraoperative
Operative Time
The total operative time will be assessed.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start23 Aug 2023
- Primary completion6 Dec 2024
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Women undergoing cesarean delivery will be recruited and randomized to skin closure with either the Dermabond Prineo system or standard subcuticular suture.
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Russell Miller, Columbia University
- Investigators
- Russell Miller, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903547
- Sponsor's protocol ID
- AAAT9584
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2023
- Last updated
- 7 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Goto S, Sakamoto T, Ganeko R, Hida K, Furukawa TA, Sakai Y. Subcuticular sutures for skin closure in non-obstetric surgery. Cochrane Database Syst Rev. 2020 Apr 9;4(4):CD012124. doi: 10.1002/14651858.CD012124.pub2.
PubMed 32271475Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4.
PubMed 25431843van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
PubMed 16079683Fleisher J, Khalifeh A, Pettker C, Berghella V, Dabbish N, Mackeen AD. Patient satisfaction and cosmetic outcome in a randomized study of cesarean skin closure. J Matern Fetal Neonatal Med. 2019 Nov;32(22):3830-3835. doi: 10.1080/14767058.2018.1474870. Epub 2018 May 24.
PubMed 29739243
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glue Versus Subcuticular Suture for Cesarean Closure: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05903547
- Acronym / sponsor ID
- AAAT9584
- Conditions
- Cesarean Section, Complication, Wound
- Keywords
- Complications, Wound, Hematoma, Surgical Incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.
Detailed description
The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women undergoing cesarean delivery will be recruited and randomized to skin closure with either the Dermabond Prineo system or standard subcuticular suture.
| Arm | Type | Receives |
|---|---|---|
| Dermabond Prineo Group | Active comparator | Device: Dermabond PrineoAt time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system. |
| Suture Group | Placebo comparator | Other: SutureAt time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women age 18 years or older
- All women scheduled for primary or repeat cesarean deliveries
- All women undergoing intrapartum or antepartum cesarean delivery
- Pfannenstiel skin incision
- Birth of a live infant at time of cesarean delivery
Key exclusion criteria (7 listed)
- Vertical skin incision
- Cesarean hysterectomy
- Emergency or stat cesarean delivery excluding standard preoperative preparation measures (i.e., use of Chlorhexidine skin prep, vaginal prep, etc)
- Intrapartum stillbirth
- Planned postpartum follow up at another facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermabond PrineoFor subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines. | Device | Dermabond Prineo Group |
| SutureFor subjects in the Suture group, the skin will be closed with the standard subcuticular suture method. | Other | Suture Group |
Primary outcome
Patient Scar Satisfaction Scale Score
Time frame: Assessed at 6-weeks postpartum
The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction.
3 secondary outcomes
Incidence of Surgical Site Infection (SSI)
Time frame: Assessed during delivery hospitalization and at 6-week follow-up
Skin Closure Time
Time frame: Intraoperative
Operative Time
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32271475Goto S, Sakamoto T, Ganeko R, Hida K, Furukawa TA, Sakai Y. Subcuticular sutures for skin closure in non-obstetric surgery. Cochrane Database Syst Rev. 2020 Apr 9;4(4):CD012124. doi: 10.1002/14651858.CD012124.pub2.
- Background: PubMed 25431843Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4.
- Background: PubMed 16079683van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
- Background: PubMed 29739243Fleisher J, Khalifeh A, Pettker C, Berghella V, Dabbish N, Mackeen AD. Patient satisfaction and cosmetic outcome in a randomized study of cesarean skin closure. J Matern Fetal Neonatal Med. 2019 Nov;32(22):3830-3835. doi: 10.1080/14767058.2018.1474870. Epub 2018 May 24.
- Dermabond PrineoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
RecruitingObservational study
Respiratory Distress and Elective Cesarean Section at Term
Respiratory Distress Syndrome
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell Miller, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermabond Prineo and Suture in people with Cesarean Section and Complication, run by Columbia University at 1 site in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 7 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Scar Satisfaction Scale Score (time frame: Assessed at 6-weeks postpartum). 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 NCT05903547, which also lists 4 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 7 Apr 2026.