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Completed

NCT Number: NCT01656044

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

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

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Primary Peritoneal Cavity Cancer Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wound care management

Procedure

Receive SSD

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

    Time frame: 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 outcomes

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

    Time frame: 30 days

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

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2012
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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