Needle-Aspirated Compression Dressing Following Ostomy Reversal

NCT03703661 | Unknown Phase 3

• 1 other identifier: HS-16-00812
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Colostomy Stoma; Ileostomy - Stoma; Surgical Site Infection; Wound Complication

Keywords

negative pressure wound therapy

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  Surgical Site Infection

  30 days post procedure

Secondary Outcomes (1)

• Rate of Wound Closure

  3 weeks post procedure and 12 weeks post procedure

Study Arms (2)

Control

OTHER

primary closure with gauze and adhesive/occlusive dressing

Procedure: Control

Negative Pressure

EXPERIMENTAL

primary closure with gauze and adhesive/occlusive dressing under negative pressure

Procedure: Needle-Aspirated Negative Pressure Dressing

Interventions

Needle-Aspirated Negative Pressure Dressing PROCEDURE

dressing consisting of Needle-Aspirated Negative Pressure dressing with gauze and adhesive/occlusive dressing, placed over wound after primary closure

Negative Pressure

Control PROCEDURE

dressing consisting of gauze and adhesive/occlusive dressing, placed over wound after primary closure

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sang W Lee, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Surgery, Chief, Division of Colorectal Surgery

Model Details: prospective randomized controlled trial

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: August 27, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)