Randomized Clinical Trial of Skin Closure With Staples Versus Suture
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/14/2017 |
| Start Date: | May 2013 |
| End Date: | June 2016 |
Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30
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.
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.
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.
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.
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