Needle-Aspirated Compression Dressing Following Ostomy Reversal



Status:Enrolling by invitation
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:10/19/2018
Start Date:August 27, 2017
End Date:August 1, 2019

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Can a Low Cost, Simple Needle-Aspirated Compression Dressing Reduce Surgical Site Infection Rates of Primarily Closed Ileostomy and Colostomy Reversal Wounds?

Negative pressure wound dressings have been studied and shown to have applications in
decreasing rates of surgical wound infections. This study studies the effect of a low cost
needle-aspirated negative pressure compression dressing on rates of wound infection at prior
ostomy site in patients undergoing ostomy reversal surgery.

Negative Pressure Wound Therapy (NPWT) will be studied in colorectal surgery patients
undergoing ostomy reversal surgery. The immediate goal is to compare primary wound closure
against primary closure with needle-aspirated compression dressing, and determine if risk of
potential ostomy site wound infections is decreased. The investigators would also like to
evaluate if this compression dressing can increase prevalence of complete wound closure by 12
weeks (last planned clinic visit). NPWT using a continuous suction device was shown to
decrease surgical site infection (SSI) at ostomy reversal sites undergoing primary closure.
There is a lack of published literature studying NPWT dressings without an associated suction
device. The investigators will be using a low-cost simple needle-aspirated suction technique
to provide negative pressure under a tegaderm/gauze dressing, at the time of placement.
Patients will be consented and randomized into a negative pressure group, or a control group
consisting of the same dressing under normal pressure. All adult patients undergoing ostomy
reversal surgery who consent to the study will be included. Exclusion criteria include prior
recurrent skin infections, prior stoma-site infection, or large parastomal hernia. Patients
in the negative pressure group will have the pressure under the dressing measured immediately
prior to removal on post-operative day 2.

Inclusion Criteria:

- at least 18 years of age

- presence of a loop or end colostomy or ileostomy

- consenting to study and to ostomy reversal

Exclusion Criteria:

- altered mental status or patients unable to sign the informed consent form

- vulnerable patient populations such as prison and ward patients

- patients who are discovered before or during surgery as unable to undergo placement of
compression dressing will be excluded.

- Patients with visible protrusion/evidence of large parastomal hernia

- history of recurrent skin & soft tissue infections

- history of previous stoma site infection or complications

- patients with extensive comorbidities (such as cancer involving stoma site,
uncontrolled diabetes, etc), Crohn's patients and abdominal wall fistula patients

- patients in who primary closure of wound is deemed inappropriate by the operating
surgeon, requiring a different method of stoma site wound management
We found this trial at
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Los Angeles, California 90033
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