Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

Wound Heal Clinical Trial

Official title:

Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112640
• Other study ID #: 21-0045
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: Brett Goldman, MD
• Phone: 9542632359
• Email: brgoldma[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Operative Time
• Wound Heal

Intervention

Device:
• INSORB: subcuticular stapling device
Under the skin stapling device that delivers absorbable staples
• Subcuticular monocryl suture manufactured by Ethicon
Under the skin suture placed by hand

Locations

Country	Name	City	State
United States	John Sealy Hospital at University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Cooper Companies

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating time	Total time for the procedure	Start of surgery through end of skin closure
Secondary	Wound cosmesis	A digital photograph of the incision will be obtained on wound check visit POD 5-10 days and 4-6 weeks postoperative. Each photograph will be evaluated according to objective criteria (width, elevation, color, marks, and general appearance) by independent blinded research staff	Time of surgery through six weeks post partum
Secondary	Composite wound complication	Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers	Time of surgery through six weeks post partum
Secondary	Post operative pain	Pain scale ranging from 0-10 on postoperative days 1 to 3 as well as at wound check visit recorded by nursing staff	Time of surgery through six weeks post partum
Secondary	Adverse events	Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis	Time of surgery through six weeks post partum
Secondary	Use of resources	Hospital stay, postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures	Time of surgery through six weeks post partum
Secondary	Patient satisfaction	Questionnaire POD 2-3 (before discharge) and at wound check visit	Time of surgery through six weeks post partum