Needle-Aspirated Compression Dressing Following Ostomy Reversal

NCT ID: NCT03703661

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-27
• Study Completion Date: 2019-08-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Negative Pressure

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

Group Type: EXPERIMENTAL

Needle-Aspirated Negative Pressure Dressing

Intervention Type: PROCEDURE

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

Control

primary closure with gauze and adhesive/occlusive dressing

Group Type: OTHER

Control

Intervention Type: PROCEDURE

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

Interventions

Needle-Aspirated Negative Pressure Dressing

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

Intervention Type: PROCEDURE

Control

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Sang Won Lee

Professor of Clinical Surgery, Chief, Division of Colorectal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang W Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

Other Identifiers

HS-16-00812

Identifier Type: -

Identifier Source: org_study_id