Needle-Aspirated Compression Dressing Following Ostomy Reversal

• Sponsor: University of Southern California (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03703661
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.1
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colostomy Stoma; Ileostomy - Stoma; Surgical Site Infection; Wound Complication	Procedure: Needle-Aspirated Negative Pressure Dressing; Procedure: Control	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: prospective randomized controlled trialprospective randomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Can a Low Cost, Simple Needle-Aspirated Compression Dressing Reduce Surgical Site Infection Rates of Primarily Closed Ileostomy and Colostomy Reversal Wounds?
• Actual Study Start Date: Aug 27, 2017
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Control primary closure with gauze and adhesive/occlusive dressing	Procedure: Control; dressing consisting of gauze and adhesive/occlusive dressing, placed over wound after primary closure
Experimental: Negative Pressure primary closure with gauze and adhesive/occlusive dressing under negative pressure	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

Outcome Measures

Primary Outcome Measures

1. Surgical Site Infection [30 days post procedure]

   Surgical Site Infection

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

• Principal Investigator: Sang W Lee, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sang Won Lee, Professor of Clinical Surgery, Chief, Division of Colorectal Surgery, University of Southern California
• ClinicalTrials.gov Identifier: NCT03703661
• Other Study ID Numbers: HS-16-00812
• First Posted: Oct 12, 2018
• Last Update Posted: Oct 17, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sang Won Lee, Professor of Clinical Surgery, Chief, Division of Colorectal Surgery, University of Southern California: negative pressure wound therapy
• Additional relevant MeSH terms: Infections; Surgical Wound Infection

Study Results

No Results Posted as of Oct 17, 2018