Study Summary
This trial is testing whether or not subcuticular absorbable staples improve operative time and wound cosmetics in cesarean sections.
- Operative Time
- Wound Healing
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Time of surgery through six weeks post partum
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Suture wound closure
1 of 2
Absorbable staple wound closure
1 of 2
Active Control
Experimental Treatment
316 Total Participants · 2 Treatment Groups
Primary Treatment: INSORB: subcuticular stapling device · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 50 · Female Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Rousseau, Julie-Anne, Karine Girard, Lucile Turcot-Lemay, and Nancy Thomas. 2009. “A Randomized Study Comparing Skin Closure in Cesarean Sections: Staples Vs Subcuticular Sutures”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2009.01.019.
- Gaertner, Isabell, Tilo Burkhardt, and Ernst Beinder. 2008. “Scar Appearance of Different Skin and Subcutaneous Tissue Closure Techniques in Caesarean Section: A Randomized Study”. European Journal of Obstetrics & Gynecology and Reproductive Biology. Elsevier BV. doi:10.1016/j.ejogrb.2007.07.003.
- Schrufer-Poland, Tabitha L., Maria P. Ruiz, Samuel Kassar, Christopher Tomassian, Stacey D. Algren, and John D. Yeast. 2016. “Incidence of Wound Complications in Cesarean Deliveries Following Closure with Absorbable Subcuticular Staples Versus Conventional Skin Closure Techniques”. European Journal of Obstetrics & Gynecology and Reproductive Biology. Elsevier BV. doi:10.1016/j.ejogrb.2016.07.501.
- Rousseau, Julie-Anne, Karine Girard, Lucile Turcot-Lemay, and Nancy Thomas. 2009. “A Randomized Study Comparing Skin Closure in Cesarean Sections: Staples Vs Subcuticular Sutures”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2009.01.019.
- Fick, Jennifer L., Roberto E. Novo, and Nicole Kirchhof. 2005. “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”. American Journal of Veterinary Research. American Veterinary Medical Association (AVMA). doi:10.2460/ajvr.2005.66.1975.
- Pineros-Fernandez, Angela, Lisa S. Salopek, Pamela F. Rodeheaver, David B. Drake, Richard Edlich, and George T. Rodeheaver. 2006. “A Revolutionary Advance in Skin Closure Compared to Current Methods”. Journal of Long-term Effects of Medical Implants. Begell House. doi:10.1615/jlongtermeffmedimplants.v16.i1.30.
- Nitsche, Joshua, Connor Howell, and Thomas Howell. 2011. “Skin Closure with Subcuticular Absorbable Staples After Cesarean Section Is Associated with Decreased Analgesic Use”. Archives of Gynecology and Obstetrics. Springer Science and Business Media LLC. doi:10.1007/s00404-011-2121-5.
- 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.
- 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.
- Goldman, Brett R 2021. "Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05112640.
Frequently Asked Questions
How many volunteers are participating in this clinical experiment?
"Affirmative. As per the records on clinicaltrials.gov, this research project is actively enrolling participants. This medical experiment was introduced to the public on November 16th 2021 and recently revised on that same date; with 316 individuals needed for participation across 1 site." - Anonymous Online Contributor
Are there any vacancies remaining for participants in this clinical investigation?
"Affirmative. According to clinicaltrials.gov, this trial is currently seeking out participants for recruitment. It was first made available on November 16th 2021 and has since been revised one time as of the same date; its target sample size being 316 from a single medical centre." - Anonymous Online Contributor
Does this research accommodate elderly participants over 75 years old?
"This experiment is only open to adults aged 18 - 50. Concurrently, there are 7 trials specifically designed for minors and 37 studies dedicated to those over the age of 65." - Anonymous Online Contributor
Who is eligible to be involved in this research initiative?
"To be eligible to participate in this scientific research, individuals must possess wound healing capabilities and meet the age requirements of 18-50. The total number of participants needed is 316." - Anonymous Online Contributor