Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Phase 2

Completed

Interventions: Device: Stainless steel staples
Device: 4-0 monofilament suture

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Stainless Steel Staples	Stainless steel staples	Skin closure with stainless steel staples
4-0 monofilament Sutures	4-0 monofilament suture	Skin closure with 4-0 monofilament sutures

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of Wound Disruption	4-8 weeks post-surgery
Incidence of Wound Infection	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.
Operative Time	During surgery	Time from skin incision to the end of skin closure
Analog Pain Score on Postoperative Days 3-4	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.
Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score	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
Median Patient Satisfaction Score of Scar Appearance	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%.

Locations (1): Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States