Clinical trial NCT05903547: Skin Glue Cesarean Study
Official title: Glue Versus Subcuticular Suture for Cesarean Closure: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cesarean Section
Complication
Wound
Keywords: Complications
Wound
Hematoma
Surgical Incision
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women undergoing cesarean delivery will be recruited and randomized to skin closure with either the Dermabond Prineo system or standard subcuticular suture.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient scar satisfaction
timeFrame: Up to 6 weeks post-surgery
Secondary outcomes:
measure: Incidence of surgical site infection (SSI)
timeFrame: Up to 6 weeks post-surgery
measure: Skin closure time
timeFrame: Intraoperative
measure: Operative time
timeFrame: Intraoperative
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center/NYP
state: New York
Study officials:
affiliation: Columbia University
name: Russell Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.