Wound Heal Clinical Trial
Official title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | John Sealy Hospital at University of Texas Medical Branch | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston | Cooper Companies |
United States,
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
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 |
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