Randomized Clinical Trial of Skin Closure With Staples Versus Suture
NCT ID: NCT01977612
Last Updated: 2017-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
173 participants
INTERVENTIONAL
2013-05-15
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stainless Steel Staples
Skin closure with stainless steel staples
Stainless steel staples
Skin closure using stainless steel staples.
4-0 monofilament Sutures
Skin closure with 4-0 monofilament sutures
4-0 monofilament suture
Skin closure using 4-0 monofilament suture
Interventions
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4-0 monofilament suture
Skin closure using 4-0 monofilament suture
Stainless steel staples
Skin closure using stainless steel staples.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index \>=30
* Benign or oncologic indications for surgery.
* Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
* Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine.
* Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria
* Pfannenstiel or transverse abdominal incision
* Concomitant panniculectomy or plastic surgery
* Women \<18 years of age
* History of prior abdominal or pelvic radiation
* Inability to sign an informed consent form prior to registration on study
* Inability to understand spoken or written English
* Prisoner
* Mental incapacity
* A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.
18 Years
85 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Lindsay Kuroki, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.
Nugent EK, Hoff JT, Gao F, Massad LS, Case A, Zighelboim I, Mutch DG, Thaker PH. Wound complications after gynecologic cancer surgery. Gynecol Oncol. 2011 May 1;121(2):347-52. doi: 10.1016/j.ygyno.2011.01.026. Epub 2011 Feb 15.
Cardosi RJ, Drake J, Holmes S, Tebes SJ, Hoffman MS, Fiorica JV, Roberts WS, Grendys EC Jr. Subcutaneous management of vertical incisions with 3 or more centimeters of subcutaneous fat. Am J Obstet Gynecol. 2006 Aug;195(2):607-14; discussion 614-6. doi: 10.1016/j.ajog.2006.04.013. Epub 2006 Jun 21.
Gallup DC, Gallup DG, Nolan TE, Smith RP, Messing MF, Kline KL. Use of a subcutaneous closed drainage system and antibiotics in obese gynecologic patients. Am J Obstet Gynecol. 1996 Aug;175(2):358-61; discussion 362. doi: 10.1016/s0002-9378(96)70146-1.
Soisson AP, Olt G, Soper JT, Berchuck A, Rodriguez G, Clarke-Pearson DL. Prevention of superficial wound separation with subcutaneous retention sutures. Gynecol Oncol. 1993 Dec;51(3):330-4. doi: 10.1006/gyno.1993.1299.
Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.
Magann EF, Chauhan SP, Rodts-Palenik S, Bufkin L, Martin JN Jr, Morrison JC. Subcutaneous stitch closure versus subcutaneous drain to prevent wound disruption after cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol. 2002 Jun;186(6):1119-23. doi: 10.1067/mob.2002.123823.
Ramsey PS, White AM, Guinn DA, Lu GC, Ramin SM, Davies JK, Neely CL, Newby C, Fonseca L, Case AS, Kaslow RA, Kirby RS, Rouse DJ, Hauth JC. Subcutaneous tissue reapproximation, alone or in combination with drain, in obese women undergoing cesarean delivery. Obstet Gynecol. 2005 May;105(5 Pt 1):967-73. doi: 10.1097/01.AOG.0000158866.68311.d1.
Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.
Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.
de Graaf IM, Oude Rengerink K, Wiersma IC, Donker ME, Mol BW, Pajkrt E. Techniques for wound closure at caesarean section: a randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):47-52. doi: 10.1016/j.ejogrb.2012.07.019. Epub 2012 Aug 19.
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.
Clay FS, Walsh CA, Walsh SR. Staples vs subcuticular sutures for skin closure at cesarean delivery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2011 May;204(5):378-83. doi: 10.1016/j.ajog.2010.11.018. Epub 2010 Dec 31.
Tuuli MG, Rampersad RM, Carbone JF, Stamilio D, Macones GA, Odibo AO. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2011 Mar;117(3):682-690. doi: 10.1097/AOG.0b013e31820ad61e.
Mackeen AD, Berghella V, Larsen ML. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD003577. doi: 10.1002/14651858.CD003577.pub3.
Shetty AA, Kumar VS, Morgan-Hough C, Georgeu GA, James KD, Nicholl JE. Comparing wound complication rates following closure of hip wounds with metallic skin staples or subcuticular vicryl suture: a prospective randomised trial. J Orthop Surg (Hong Kong). 2004 Dec;12(2):191-3. doi: 10.1177/230949900401200210.
Haymer DS, Marsh JL. Germ line and somatic instability of a white mutation in Drosophila mauritiana due to a transposable genetic element. Dev Genet. 1986;6(4):281-91. doi: 10.1002/dvg.1020060406.
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.
Kuroki LM, Mullen MM, Massad LS, Wu N, Liu J, Mutch DG, Powell MA, Hagemann AR, Thaker PH, McCourt CK, Novetsky AP. Wound Complication Rates After Staples or Suture for Midline Vertical Skin Closure in Obese Women: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):91-99. doi: 10.1097/AOG.0000000000002061.
Other Identifiers
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201304058
Identifier Type: -
Identifier Source: org_study_id
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