Clinical trial NCT05112640: Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery
Official title: Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Operative Time
Wound Heal
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Cooper Companies
First posted: 2021-11-09
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation
Primary purpose: OTHER

Brief summary: Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.

Detailed description: This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.

Eligibility criteria: Inclusion Criteria:

* 18-50 years of age
* Women ≥ 24 weeks viable gestation
* Will be undergoing cesarean delivery

Exclusion Criteria:

* Patient unwilling or unable to provide consent.
* No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.
* Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 \<200, or other
* Decision not to have skin closure (e.g. secondary wound closure, mesh closure)
* Current skin infection
* Coagulopathy
* High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)
* Incarcerated individuals
* Intraamniotic infection
* Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.

Primary outcomes:
measure: Operating Time
timeFrame: Start of surgery through end of skin closure in minutes
Secondary outcomes:
measure: Wound Cosmesis
timeFrame: Time of surgery through six weeks post partum
measure: Number of Participants With Composite Wound Complication
timeFrame: Time of surgery through six weeks post partum
measure: Post Operative Pain
timeFrame: 5-10 days
measure: Number of Adverse Events
timeFrame: Time of surgery through six weeks post partum
measure: Use of Resources
timeFrame: Time of surgery through six weeks post partum
measure: Skin Closure Time in Minutes
timeFrame: Time of surgery through six weeks post partum
Other outcomes:
Locations:
city: Galveston
country: United States
facility: John Sealy Hospital at University of Texas Medical Branch
state: Texas
Study officials:
References:
citation: Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
citation: Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.
citation: Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019.
citation: Fick JL, Novo RE, Kirchhof N. Comparison of gross and histologic tissue responses of skin incisions closed by use of absorbable subcuticular staples, cutaneous metal staples, and polyglactin 910 suture in pigs. Am J Vet Res. 2005 Nov;66(11):1975-84. doi: 10.2460/ajvr.2005.66.1975.
citation: Pineros-Fernandez A, Salopek LS, Rodeheaver PF, Drake DB, Edlich RF, Rodeheaver GT. A revolutionary advance in skin closure compared to current methods. J Long Term Eff Med Implants. 2006;16(1):19-27. doi: 10.1615/jlongtermeffmedimplants.v16.i1.30.
citation: Nitsche J, Howell C, Howell T. Skin closure with subcuticular absorbable staples after cesarean section is associated with decreased analgesic use. Arch Gynecol Obstet. 2012 Apr;285(4):979-83. doi: 10.1007/s00404-011-2121-5. Epub 2011 Oct 30.
citation: Schrufer-Poland TL, Ruiz MP, Kassar S, Tomassian C, Algren SD, Yeast JD. Incidence of wound complications in cesarean deliveries following closure with absorbable subcuticular staples versus conventional skin closure techniques. Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:53-56. doi: 10.1016/j.ejogrb.2016.07.501. Epub 2016 Aug 3.