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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01656044
First received: July 31, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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 Intervention
Colon Cancer
Pancreatic Cancer
Perioperative/Postoperative Complications
Primary Peritoneal Cavity Cancer
Rectal Cancer
Procedure: wound care management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: June 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656044

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Perry Shen    336-713-6913    pshen@wfubmc.edu   
Principal Investigator: Perry Shen         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Perry Shen Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01656044     History of Changes
Other Study ID Numbers: CCCWFU 99212, NCI-2012-00624
Study First Received: July 31, 2012
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Pancreatic Neoplasms
Peritoneal Neoplasms
Postoperative Complications
Abdominal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Pathologic Processes
Peritoneal Diseases

ClinicalTrials.gov processed this record on October 23, 2014