Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Wound Infection Clinical Trial

Official title:

Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977612
• Other study ID #: 201304058
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2013
• Last updated: July 26, 2017
• Start date: May 15, 2013
• Est. completion date: June 30, 2016

Study information

• Verified date: July 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.

Description:

The investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (BMI>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the Division of Gynecologic Oncology at Washington University School of Medicine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 30, 2016
• Est. primary completion date: June 17, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• All women, >=18 and <= 85 years of age, undergoing surgery, via a midline laparotomy.

• 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:

• Women who are pregnant or breastfeeding

• 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.

Related Conditions & MeSH terms

• Wound Complication
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• 4-0 monofilament suture
Skin closure using 4-0 monofilament suture
• Stainless steel staples
Skin closure using stainless steel staples.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View Citation

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. Epub 2006 Jun 21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: http://10.1097/AOG.0b013e31827a072c. Erratum in: Obstet Gynecol. 2013 May;121(5):1113. — 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

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. — View Citation

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. — View Citation

Mackeen AD, Berghella V, Larsen ML. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2012 Nov 14;11:CD003577. doi: 10.1002/14651858.CD003577.pub3. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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):1892-7. — View Citation

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. — View Citation

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):682-90. doi: 10.1097/AOG.0b013e31820ad61e. Review. Erratum in: Obstet Gynecol. 2011 Jun;117(6):1440. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.		4-8 weeks post-surgery
Secondary	Incidence of Wound Disruption		4-8 weeks post-surgery
Secondary	Incidence of Wound Infection	Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.	4-8 weeks post-surgery
Secondary	Operative Time	Time from skin incision to the end of skin closure	During surgery
Secondary	Analog Pain Score on Postoperative Days 3-4	The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.	3-4 days post-surgery
Secondary	Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score	Ranges from 0 (worst) to 5 (best); Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0	4-8 weeks post-operative
Secondary	Median Patient Satisfaction Score of Scar Appearance	Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated "very unsatisfied" or 0% and the end of the line was "very satisfied" or 100%.	4-8 weeks post-operative