Needle-Aspirated Compression Dressing Following Ostomy Reversal

Surgical Site Infection Clinical Trial

Official title:

Can a Low Cost, Simple Needle-Aspirated Compression Dressing Reduce Surgical Site Infection Rates of Primarily Closed Ileostomy and Colostomy Reversal Wounds?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03703661
• Other study ID #: HS-16-00812
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: August 27, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 122
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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
• Control
dressing consisting of gauze and adhesive/occlusive dressing, placed over wound after primary closure

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection	Surgical Site Infection	30 days post procedure
Secondary	Rate of Wound Closure	rate of wound closure at 3 weeks post procedure and 12 weeks post procedure	3 weeks post procedure and 12 weeks post procedure