Clinical trial NCT03703661: Needle-Aspirated Compression Dressing Following Ostomy Reversal
Official title: Can a Low Cost, Simple Needle-Aspirated Compression Dressing Reduce Surgical Site Infection Rates of Primarily Closed Ileostomy and Colostomy Reversal Wounds?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colostomy Stoma
Ileostomy - Stoma
Surgical Site Infection
Wound Complication
Keywords: negative pressure wound therapy
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Rate of Wound Closure
timeFrame: 3 weeks post procedure and 12 weeks post procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Sang W Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: