Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Operating time [Start of surgery through end of skin closure]
Total time for the procedure
Secondary Outcome Measures
- Wound cosmesis [Time of surgery through six weeks post partum]
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
- Composite wound complication [Time of surgery through six weeks post partum]
Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers
- Post operative pain [Time of surgery through six weeks post partum]
Pain scale ranging from 0-10 on postoperative days 1 to 3 as well as at wound check visit recorded by nursing staff
- Adverse events [Time of surgery through six weeks post partum]
Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis
- Use of resources [Time of surgery through six weeks post partum]
Hospital stay, postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures
- Patient satisfaction [Time of surgery through six weeks post partum]
Questionnaire POD 2-3 (before discharge) and at wound check visit
Eligibility Criteria
Criteria
Inclusion Criteria:
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18-50 years of age
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Women ≥ 24 weeks viable gestation
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Will be undergoing cesarean delivery
Exclusion Criteria:
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Patient unwilling or unable to provide consent.
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No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.
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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
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Decision not to have skin closure (e.g. secondary wound closure, mesh closure)
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Current skin infection
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Coagulopathy
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High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)
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Incarcerated individuals
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Intraamniotic infection
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Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | John Sealy Hospital at University of Texas Medical Branch | Galveston | Texas | United States | 77555 |
Sponsors and Collaborators
- The University of Texas Medical Branch, Galveston
- Cooper Companies
Investigators
- Principal Investigator: George Saade, MD, Division Director/Co-PI
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Epub 2007 Sep 6.
- 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.
- Piñeros-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.
- 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.
- 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.
- 21-0045