Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Phase 2CompletedNCT01977612

Washington University School of Medicine173 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

173

Conditions

Wound Infection Wound Complication

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Incidence of Wound Disruption

Time frame: 4-8 weeks post-surgery

Incidence of Wound Infection

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

Time frame: 4-8 weeks post-surgery

Operative Time

Time from skin incision to the end of skin closure

Time frame: During surgery

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.

Time frame: 3-4 days post-surgery

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

Time frame: 4-8 weeks post-operative

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%.

Time frame: 4-8 weeks post-operative

Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes