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Wound InfectionPhase 2NCT01977612

Randomized Clinical Trial of Skin Closure With Staples Versus Suture

A Phase 2 study testing 4-0 monofilament suture and Stainless steel staples in people with Wound Infection and Wound Complication, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years, women only
Conditions the study is for
Wound Infection, Wound Complication
What is being tested?
4-0 monofilament suture and Stainless steel staples
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
1 siteUnited States
Study dates
15 May 2013to 30 Jun 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • Inability to understand spoken or written English
  • Prisoner
  • Mental incapacity
  • A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
4-0 monofilament suture, Stainless steel staples
Keywords
Wound infection, Wound separation, Skin staples, Subcuticular suture
Medical subject headings
Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4-0 monofilament sutureDevice

    Also called 4-0 Monocryl suture

    Skin closure using 4-0 monofilament suture

  • Stainless steel staplesDevice

    Skin closure using stainless steel staples.

Study groups in NCT01977612
Study groupRoleWhat they receive
Stainless Steel StaplesActive comparatorSkin closure with stainless steel staples
Receives: Device: Stainless steel staples
4-0 monofilament SuturesExperimentalSkin closure with 4-0 monofilament sutures
Receives: Device: 4-0 monofilament suture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.

    Measured: 4-8 weeks post-surgery

Secondary outcomes (6)

  1. Incidence of Wound Disruption

    Measured: 4-8 weeks post-surgery

  2. Incidence of Wound Infection

    Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.

    Measured: 4-8 weeks post-surgery

  3. Operative Time

    Time from skin incision to the end of skin closure

    Measured: During surgery

  4. 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.

    Measured: 3-4 days post-surgery

  5. 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

    Measured: 4-8 weeks post-operative

  6. 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%.

    Measured: 4-8 weeks post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2013 (estimated)
  2. Study start15 May 2013
  3. Primary completion17 Jun 2016
  4. Study completion30 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01977612
Sponsor's protocol ID
201304058
Status last verified
Jul 2017
First submitted
17 Apr 2013
Last updated
31 Jul 2017
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 12603990

  • 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.

    PubMed 21324517

  • 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.

    PubMed 16796988

  • 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.

    PubMed 8765253

  • 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.

    PubMed 8112641

  • 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.

    PubMed 21079110

  • 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.

    PubMed 12066083

  • 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.

    PubMed 15863532

  • 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.

    PubMed 23262925

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

    PubMed 9350017

  • 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.

    PubMed 20417924

  • 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.

    PubMed 22910336

  • 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.

    PubMed 19254586

  • 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.

    PubMed 21195384

  • 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.

    PubMed 21343772

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 4-0 monofilament suture and Stainless steel staples in people with Wound Infection and Wound Complication, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. (time frame: 4-8 weeks post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01977612, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.

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