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

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

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.

Study Overview

• Status: Terminated
• Conditions: Wound Heal; Operative Time
• Intervention / Treatment: Device: Subcuticular monocryl suture manufactured by Ethicon; Device: INSORB: subcuticular stapling device

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • John Sealy Hospital at University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Suture wound closure; Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon.	Device: Subcuticular monocryl suture manufactured by Ethicon; Under the skin suture placed by hand
Experimental: Absorbable staple wound closure; Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical.	Device: INSORB: subcuticular stapling device; Under the skin stapling device that delivers absorbable staples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating Time	Total time for the procedure	Start of surgery through end of skin closure in minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Cosmesis	A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale.These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing.	Time of surgery through six weeks post partum
Number of Participants With Composite Wound Complication	Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers	Time of surgery through six weeks post partum
Post Operative Pain	Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart. A score of 0 means no pain, and 10 means the worst pain.	5-10 days
Number of Adverse Events	Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis	Time of surgery through six weeks post partum
Use of Resources	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
Skin Closure Time in Minutes	The average of minutes it takes for closure of the skin at time of surgery through weeks post partum.	Time of surgery through six weeks post partum

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Cooper Companies
• Investigators: Principal Investigator: George Saade, MD, Division Director/Co-PI

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21-0045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Do not plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes