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The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections


N/A
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Pancreatic Cancer, Perioperative/Postoperative Complications, Primary Peritoneal Cavity Cancer, Rectal Cancer

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Trial Information

The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Perry Shen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 99212

NCT ID:

NCT01656044

Start Date:

June 2012

Completion Date:

Related Keywords:

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

Name

Location

Comprehensive Cancer Center of Wake Forest University Winston-Salem, North Carolina  27157-1082