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

Pancreatic Cancer Clinical Trial

Official title:

The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656044
• Other study ID #: IRB00020105
• Secondary ID: NCI-2012-00624CC
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: October 2016

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• wound care management
Receive SSD
• wound care management
Receive NPT

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason		30 days
Secondary	The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients		30 days