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NCT Number: NCT01977612

Randomized Clinical Trial of Skin Closure With Staples Versus Suture

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.

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Key information

Conditions

Wound Infection Infections Wound Complication

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4-0 monofilament suture

Device

Skin closure using 4-0 monofilament suture

Other names: 4-0 Monocryl suture

Stainless steel staples

Device

Skin closure using stainless steel staples.

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.

    Time frame: 4-8 weeks post-surgery

Secondary outcomes

  1. Incidence of Wound Disruption

    Time frame: 4-8 weeks post-surgery

  2. Incidence of Wound Infection

    Time frame: 4-8 weeks post-surgery

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

  3. Operative Time

    Time frame: During surgery

    Time from skin incision to the end of skin closure

  4. Analog Pain Score on Postoperative Days 3-4

    Time frame: 3-4 days post-surgery

    The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.

  5. Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score

    Time frame: 4-8 weeks post-operative

    • 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

  6. Median Patient Satisfaction Score of Scar Appearance

    Time frame: 4-8 weeks post-operative

    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%.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2013
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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