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

NCT05112640 | Terminated Results FDA Device

• 1 other identifier: 21-0045
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Operative Time; Wound Heal

Outcome Measures

Primary Outcomes (1)

• Operating Time

  Total time for the procedure

  Start of surgery through end of skin closure in minutes

Secondary Outcomes (6)

• Wound Cosmesis

  Time of surgery through six weeks post partum

• Number of Participants With Composite Wound Complication

  Time of surgery through six weeks post partum

• Post Operative Pain

  5-10 days

• Number of Adverse Events

  Time of surgery through six weeks post partum

• Use of Resources

  Time of surgery through six weeks post partum

Study Arms (2)

Suture wound closure

ACTIVE COMPARATOR

Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon.

Device: Subcuticular monocryl suture manufactured by Ethicon

Absorbable staple wound closure

EXPERIMENTAL

Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical.

Device: INSORB: subcuticular stapling device

Interventions

INSORB: subcuticular stapling device DEVICE

Under the skin stapling device that delivers absorbable staples

Absorbable staple wound closure

Subcuticular monocryl suture manufactured by Ethicon DEVICE

Under the skin suture placed by hand

Suture wound closure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Women ≥ 24 weeks viable gestation
• Will be undergoing cesarean delivery

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Cooper Companies: collaborator

Study Sites (1)

John Sealy Hospital at University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (7)

• Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.

  PMID: 9350017 BACKGROUND

• 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.

  PMID: 17825472 BACKGROUND

• 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.

  PMID: 19254586 BACKGROUND

• 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.

  PMID: 16334959 BACKGROUND

• 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.

  PMID: 16566742 BACKGROUND

• 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.

  PMID: 22037686 BACKGROUND

• 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.

  PMID: 27632411 BACKGROUND

Results Point of Contact

• Title: Brett Goldman
• Organization: University of Texas Medical Branch

brettryangoldman@gmail.com

9542632359

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Reviewers of wound cosmetics during the post operative time will be blind to the intervention. However, surgeon at the time skin closure and patient will not be blinded to the intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 9, 2021
• Study Start: November 16, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)