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

NCT01656044 | Completed

• 3 other identifiers: IRB00020105NCI-2012-00624CCCWFU 99212
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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

Conditions

Colon Cancer; Pancreatic Cancer; Perioperative/Postoperative Complications; Primary Peritoneal Cavity Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (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

  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 Outcomes (2)

• Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason

  30 days

• The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients

  30 days

Study Arms (2)

Arm I (SSD)

ACTIVE COMPARATOR

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

Procedure: wound care management

Arm II (NPT)

EXPERIMENTAL

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

Procedure: wound care management

Interventions

wound care management PROCEDURE

Receive SSD

Arm I (SSD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Pancreatic Neoplasms; Postoperative Complications; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rectal Diseases

Study Officials

• Perry Shen

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 2, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)