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

Study Overview

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

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

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.

Colon Cancer
Pancreatic Cancer
Perioperative/Postoperative Complications
Primary Peritoneal Cavity Cancer
Rectal Cancer

PROCEDURE: wound care management
PROCEDURE: wound care management

IRB00020105
NCI-2012-00624 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
CCCWFU 99212 (OTHER Identifier) (OTHER: Wake Forest University Health Sciences)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-07-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-07-02
First Submitted that Met QC Criteria 2012-08-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-07-03
First Posted (ACTUAL) 2012-08-02	Results First Posted N/A	Last Verified 2018-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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
EXPERIMENTAL: Arm II (NPT) Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery.	PROCEDURE: wound care management Receive NPT

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

EXPERIMENTAL: Arm II (NPT)

Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery.

PROCEDURE: wound care management

Receive NPT

Primary Outcome Measures	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	Measure Description	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Perry Shen, Wake Forest University Health Sciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record