Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer

Completed · Not applicable

Conditions studied: Colon Cancer, Pancreatic Cancer, Perioperative/Postoperative Complications, Primary Peritoneal Cavity Cancer, Rectal Cancer

In brief

The purpose of this research study is to evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly-used sterile gauze incision dressing. In this study, the negative-pressure dressing will be compared to a standard post-surgical sterile gauze dressing. In this study patients will either receive a negative-pressure dressing or a standard sterile gauze dressing

Key facts

Study ID

NCT01656044

Run by

Wake Forest University Health Sciences

People needed

375

Starts

2012-06-01

Expected to finish

2016-10-01

Last updated by the study team

2018-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Surgical resection for a colorectal, pancreatic, or peritoneal surface malignancy
• The scheduled procedure will be performed via midline laparotomy
• The planned procedure is a clean-contaminated (class II) case (includes gastric, small bowel, and colorectal resections, as well as bile or pancreatic duct transections)
• Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)

You may not qualify if…

• Emergent cases will not be included in the study
• Pregnant patients will not be included in the study as pregnancy is a relative contraindication for these types of surgical procedures
• Clean (class I), contaminated (class III) and dirty (class IV) procedures will likewise be excluded
• Patients on chronic immunosuppressive medications, including steroids, within the past three months
• Patients with a history of skin allergy to iodine or adhesive drapes
• The planned procedure involves foreign material (such as mesh or subcutaneous drains) being left in the subcutaneous space at the time of surgery (for example, a ventral hernia repair); surgical drains that are placed to drain an intraabdominal space and exit the abdominal wall remote from the incision are allowed in the study

Where it is running

• Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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