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

The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Rectal Cancer; Colon Cancer; Primary Peritoneal Cavity Cancer; Perioperative/Postoperative Complications
• Intervention / Treatment: Procedure: wound care management; Procedure: wound care management

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (SSD); Patients receive SSD over their closed laparotomy incision at the conclusion of their surgery.	Procedure: wound care management; Receive SSD; Procedure: wound care management; Receive NPT
Experimental: Arm II (NPT); Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery.	Procedure: wound care management; Receive SSD; Procedure: wound care management; Receive NPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of incisional surgical site infection (SSI), which includes superficial incisional SSIs and deep incisional SSIs as defined by the Center of Disease Control and Prevention	Results will be analyzed initially using descriptive statistics. The proportion of SSI in the NPT group will be compared to the standard post-operative dressing group using a chi square test of proportions.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason	30 days
The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients	30 days

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Perry Shen, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 31, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimate): August 2, 2012

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: IRB00020105; NCI-2012-00624 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 99212 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No