Needle-Aspirated Compression Dressing Following Ostomy Reversal

Status unconfirmed · Phase 3

Conditions studied: Colostomy Stoma, Ileostomy - Stoma, Surgical Site Infection, Wound Complication

In brief

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.

Key facts

Study ID

NCT03703661

Run by

University of Southern California

People needed

122

Starts

2017-08-27

Expected to finish

2019-08-01

Last updated by the study team

2018-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• at least 18 years of age
• presence of a loop or end colostomy or ileostomy
• consenting to study and to ostomy reversal

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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