Postoperative Pain and Skin Closure Methods After Cesarean Section
NCT ID: NCT02028000
Last Updated: 2017-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2012-01-31
2016-01-01
Brief Summary
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The study hypothesis is to determine if skin closure with absorbable subcuticular staples leads to improved cosmesis and/or decreased post-operative pain.
Participants in the study will already be scheduled for a cesarean section for delivery of their baby. They will be randomized into one of three groups, 1) Insorb (absorbable subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their cesarean section. Information that will be recorded includes amount of pain medication usage while in the hospital after cesarean section, daily patient rated pain score until discharge from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks after surgery.
Detailed Description
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The topic of skin closure after cesarean delivery is an area that has been the focus of several randomized control trials. The trials compared surgical steel staples to subcuticular suture of various materials focusing on differences in post-operative pain, infection rates, and scar cosmesis. Cosmesis has been investigated in all three Randomized Clinical Trials and none have found differences between surgical steel staples and subcuticular suture. Infection rate has been studied in a single observational study which found a higher infection rate in those patients whose skin was closed with surgical steel staples compared to suture. Studies of post-operative pain and skin closure technique have been contradictory. The earliest Randomized clinical trial to investigate skin closure and post-operative pain was done by Frishman et al (5) and found that subjective self-assessment of pain was better at hospital discharge and 6 weeks post-operatively in patients when subcuticular suture rather than surgical steel staples were used. A subsequent Randomized clinical trial reported the opposite result with less pain 6 weeks post-operatively when surgical steel staples were used. This discrepancy may, in part, be due to the different suture material used in the two trials. The study by Frishman et al which showed a benefit of subcuticular suture utilized used polyglycolic acid (Vicryl suture or Insorb staples); whereas, the study by Rousseau et al used polyglecaprone (Monocryl suture). To date direct comparison of skin closure at the time of cesarean with these two suture materials has not been performed.
Recently, a new technology for skin closure has been introduced that employs absorbable material, polylactic and polyglycolic acid, in subcuticular staples. In animal models this method of skin closure has shown less histological inflammation and fewer wound infections than either surgical steel staples or subcuticular suture. Unfortunately, little is known about how this skin closure technique compares to the other more established techniques after cesarean delivery in humans. However, a retrospective analysis comparing subcuticular absorbable staples with surgical steel staples revealed an association between subcuticular absorbable staples and decreased in-hospital analgesic use. The current study is a prospective randomized trial that investigates four cesarean skin closure techniques-surgical steel staples, subcuticular polyglycolic acid suture (Vicryl), subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples-to determine if one is associated with improved cosmesis or a decrease in post-operative pain.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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INSORB staples skin closure
Women undergoing cesarean section delivery will have skin closure with INSORB staples.
Monocryl skin closure
Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.
Vicryl skin closure
Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.
Monocryl skin closure
Women undergoing cesarean section delivery will have skin closure with Monocryl.
Insorb staples skin closure
Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.
Vicryl skin closure
Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.
Vicryl skin closure
Women undergoing cesarean section delivery will have Vicryl skin closure
Insorb staples skin closure
Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.
Monocryl skin closure
Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.
Interventions
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Insorb staples skin closure
Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.
Monocryl skin closure
Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.
Vicryl skin closure
Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.
Eligibility Criteria
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Inclusion Criteria
* Any race
* Any parity
* Scheduled Cesarean Section
* Neuraxial analgesia
Exclusion Criteria
* Maternal Connective Tissue Disorder
* Maternal Steroid Use
18 Years
44 Years
FEMALE
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Joshua Nitsche, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Baptist School of Medicine
Locations
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Forsyth Medical Center
Winston-Salem, North Carolina, United States
Countries
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References
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Walsh CA. Evidence-based cesarean technique. Curr Opin Obstet Gynecol. 2010 Apr;22(2):110-5. doi: 10.1097/GCO.0b013e3283372327.
Johnson A, Young D, Reilly J. Caesarean section surgical site infection surveillance. J Hosp Infect. 2006 Sep;64(1):30-5. doi: 10.1016/j.jhin.2006.03.020. Epub 2006 Jul 5.
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.
Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2009. Natl Vital Stat Rep. 2010 Dec;59(3):1-19.
Altman AD, Allen VM, McNeil SA, Dempster J. Pfannenstiel incision closure: a review of current skin closure techniques. J Obstet Gynaecol Can. 2009 Jun;31(6):514-520. doi: 10.1016/S1701-2163(16)34213-X.
Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.
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.
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.
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.
Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.
Other Identifiers
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17928
Identifier Type: -
Identifier Source: org_study_id