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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01656044
Collaborator
National Cancer Institute (NCI) (NIH)
375
Enrollment
1
Location
2
Arms
52
Duration (Months)
7.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: wound care management
  • Procedure: wound care management
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
375 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 [30 days]

    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

  1. Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason [30 days]

  2. The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Comprehensive Cancer Center of Wake Forest University Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Perry Shen, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01656044
Other Study ID Numbers:
  • IRB00020105
  • NCI-2012-00624
  • CCCWFU 99212
First Posted:
Aug 2, 2012
Last Update Posted:
Jul 3, 2018
Last Verified:
Jul 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Postoperative Complications

Study Results

No Results Posted as of Jul 3, 2018