Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2023-08-23
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dermabond Prineo Group
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Dermabond Prineo
For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
Suture Group
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Suture
For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
Interventions
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Dermabond Prineo
For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
Suture
For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Columbia University
OTHER
Responsible Party
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Russell Miller
Sloane Hospital for Women Associate Professor of Prenatal Pediatrics
Principal Investigators
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Russell Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University Irving Medical Center/NYP
New York, New York, United States
Countries
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References
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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.
Dumville 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.
van 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.
Fleisher 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.
Related Links
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Other Identifiers
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AAAT9584
Identifier Type: -
Identifier Source: org_study_id
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