NCT01977612

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2013

Completed
28 days until next milestone

Study Start

First participant enrolled

May 15, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2016

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 31, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

3.1 years

First QC Date

April 17, 2013

Results QC Date

May 25, 2017

Last Update Submit

July 26, 2017

Conditions

Wound InfectionWound Complication

Keywords

Wound infectionWound separationSkin staplesSubcuticular suture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Incidence of Wound Disruption

    4-8 weeks post-surgery

  • Incidence of Wound Infection

    4-8 weeks post-surgery

  • Operative Time

    During surgery

  • Analog Pain Score on Postoperative Days 3-4

    3-4 days post-surgery

  • Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score

    4-8 weeks post-operative

  • +1 more secondary outcomes

Study Arms (2)

Stainless Steel Staples

ACTIVE COMPARATOR

Skin closure with stainless steel staples

Device: Stainless steel staples

4-0 monofilament Sutures

EXPERIMENTAL

Skin closure with 4-0 monofilament sutures

Device: 4-0 monofilament suture

Interventions

4-0 monofilament sutureDEVICE

Skin closure using 4-0 monofilament suture

Also known as: 4-0 Monocryl suture
4-0 monofilament Sutures
Stainless steel staplesDEVICE

Skin closure using stainless steel staples.

Stainless Steel Staples

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (21)

  • 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.

    PMID: 12603990BACKGROUND

  • 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.

    PMID: 21324517BACKGROUND

  • 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.

    PMID: 16796988BACKGROUND

  • 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.

    PMID: 8765253BACKGROUND

  • 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.

    PMID: 8112641BACKGROUND

  • 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.

    PMID: 21079110BACKGROUND

  • 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.

    PMID: 12066083BACKGROUND

  • 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.

    PMID: 15863532BACKGROUND

  • 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.

    PMID: 23262925BACKGROUND

  • Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.

    PMID: 9350017BACKGROUND

  • 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.

    PMID: 20417924BACKGROUND

  • 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.

    PMID: 22910336BACKGROUND

  • 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.

    PMID: 19254586BACKGROUND

  • 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.

    PMID: 21195384BACKGROUND

  • 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.

    PMID: 21343772BACKGROUND

  • 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.

    PMID: 23152219BACKGROUND

  • 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.

    PMID: 15621905BACKGROUND

  • 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.

    PMID: 2840224BACKGROUND

  • 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.

    PMID: 16334959BACKGROUND

  • 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.

    PMID: 18090752BACKGROUND

  • 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.

    PMID: 28594761DERIVED

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

Title
Lindsay Kuroki, M.D.
Organization
Washington University School of Medicine
kurokil@wustl.edu
314-362-2368

Study Officials

  • Lindsay Kuroki, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

November 6, 2013

Study Start

May 15, 2013

Primary Completion

June 17, 2016

Study Completion

June 30, 2016

Last Updated

July 31, 2017

Results First Posted

July 31, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)