Needle-Aspirated Compression Dressing Following Ostomy Reversal

Phase 3

• Conditions: Surgical Site Infection; Colostomy Stoma; Ileostomy - Stoma; Wound Complication
• Interventions: Procedure: Needle-Aspirated Negative Pressure Dressing; Procedure: Control

• Registration Number: NCT03703661
• Lead Sponsor: University of Southern California

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-08-27
• Status Verified: 2018-10
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-17
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure	Needle-Aspirated Negative Pressure Dressing	primary closure with gauze and adhesive/occlusive dressing under negative pressure
Control	Control	primary closure with gauze and adhesive/occlusive dressing

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection	30 days post procedure	Surgical Site Infection

Secondary Outcome Measures

Name	Time	Method
Rate of Wound Closure	3 weeks post procedure and 12 weeks post procedure	rate of wound closure at 3 weeks post procedure and 12 weeks post procedure

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States