Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Study Overview
=================
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.

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

Conditions
-----------------
Wound Infection, Wound Complication

Intervention / Treatment
-----------------
* Device: 4-0 monofilament suture
* Device: Stainless steel staples


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stainless Steel Staples<br>Skin closure with stainless steel staples | Device: Stainless steel staples<br>* Skin closure using stainless steel staples.<br>|
| Experimental: 4-0 monofilament Sutures<br>Skin closure with 4-0 monofilament sutures | Device: 4-0 monofilament suture<br>* Skin closure using 4-0 monofilament suture<br>* Other names: 4-0 Monocryl suture;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Wound Disruption |  | 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. | 4-8 weeks post-surgery | 
| Operative Time | Time from skin incision to the end of skin closure | 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. | 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 | 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%. | 4-8 weeks post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wound infection, Wound separation, Skin staples, Subcuticular suture