Needle-Aspirated Compression Dressing Following Ostomy Reversal
Status and phase
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Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
122 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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