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

Wake Forest University (WFU)

Status

Completed

Conditions

Primary Peritoneal Cavity Cancer

Perioperative/Postoperative Complications

Colon Cancer

Rectal Cancer

Pancreatic Cancer

Treatments

Procedure: wound care management

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01656044

NCI-2012-00624 (Registry Identifier)

IRB00020105

CCCWFU 99212 (Other Identifier)

Details and patient eligibility

About

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

Full description

PRIMARY OBJECTIVES:

I. To determine whether negative pressure therapy applied to closed laparotomy incisions can decrease the incidence of incisional surgical site infections in patients undergoing clean-contaminated resections for colorectal, pancreatic, and peritoneal surface malignancies compared to standard post-operative sterile gauze dressings.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive standard sterile dressing (SSD) over their closed laparotomy incision at the conclusion of their surgery.

ARM II: Patients receive negative pressure therapy (NPT) dressing over their closed laparotomy incision at the conclusion of their surgery.

After completion of study treatment, patients are followed up at 30 days.

Enrollment

375 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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