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

Primary Purpose

Colon Cancer, Pancreatic Cancer, Perioperative/Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
wound care management
wound care management
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (SSD)

Arm II (NPT)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 31, 2012
Last Updated
July 2, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01656044
Brief Title
Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer
Official Title
The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Pancreatic Cancer, Perioperative/Postoperative Complications, Primary Peritoneal Cavity Cancer, Rectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (SSD)
Arm Type
Active Comparator
Arm Description
Patients receive SSD over their closed laparotomy incision at the conclusion of their surgery.
Arm Title
Arm II (NPT)
Arm Type
Experimental
Arm Description
Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery.
Intervention Type
Procedure
Intervention Name(s)
wound care management
Intervention Description
Receive SSD
Intervention Type
Procedure
Intervention Name(s)
wound care management
Intervention Description
Receive NPT
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason
Time Frame
30 days
Title
The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry Shen
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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

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