Clinical trial NCT01977612: Randomized Clinical Trial of Skin Closure With Staples Versus Suture
Official title: Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wound Infection
Wound Complication
Keywords: Wound infection
Wound separation
Skin staples
Subcuticular suture
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.
timeFrame: 4-8 weeks post-surgery
Secondary outcomes:
measure: Incidence of Wound Disruption
timeFrame: 4-8 weeks post-surgery
measure: Incidence of Wound Infection
timeFrame: 4-8 weeks post-surgery
measure: Operative Time
timeFrame: During surgery
measure: Analog Pain Score on Postoperative Days 3-4
timeFrame: 3-4 days post-surgery
measure: Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score
timeFrame: 4-8 weeks post-operative
measure: Median Patient Satisfaction Score of Scar Appearance
timeFrame: 4-8 weeks post-operative
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Lindsay Kuroki, M.D.
role: PRINCIPAL_INVESTIGATOR
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