Randomized Clinical Trial of Skin Closure With Staples Versus Suture

Completed · Phase 2

Conditions studied: Wound Infection, Wound Complication

In brief

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.

Key facts

Study ID

NCT01977612

Run by

Washington University School of Medicine

People needed

173

Starts

2013-05-15

Expected to finish

2016-06-30

Last updated by the study team

2017-07-31

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.