Randomized Clinical Trial of Skin Closure With Staples Versus Suture
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
173 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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