Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer
This study is currently recruiting participants.
Verified February 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01656044
First received: July 31, 2012
Last updated: February 5, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2014 (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
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: | February 5, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Colonic Neoplasms Rectal Neoplasms Pancreatic Neoplasms Postoperative Complications Peritoneal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Pathologic Processes Abdominal Neoplasms Peritoneal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013