Needle-Aspirated Compression Dressing Following Ostomy Reversal
Primary Purpose
Colostomy Stoma, Ileostomy - Stoma, Surgical Site Infection
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Needle-Aspirated Negative Pressure Dressing
Control
Sponsored by
About this trial
This is an interventional treatment trial for Colostomy Stoma focused on measuring negative pressure wound therapy
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
Sites / Locations
- University of Southern California
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control
Negative Pressure
Arm Description
primary closure with gauze and adhesive/occlusive dressing
primary closure with gauze and adhesive/occlusive dressing under negative pressure
Outcomes
Primary Outcome Measures
Surgical Site Infection
Surgical Site Infection
Secondary Outcome Measures
Rate of Wound Closure
rate of wound closure at 3 weeks post procedure and 12 weeks post procedure
Full Information
NCT ID
NCT03703661
First Posted
October 9, 2018
Last Updated
October 12, 2018
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT03703661
Brief Title
Needle-Aspirated Compression Dressing Following Ostomy Reversal
Official Title
Can a Low Cost, Simple Needle-Aspirated Compression Dressing Reduce Surgical Site Infection Rates of Primarily Closed Ileostomy and Colostomy Reversal Wounds?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colostomy Stoma, Ileostomy - Stoma, Surgical Site Infection, Wound Complication
Keywords
negative pressure wound therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
primary closure with gauze and adhesive/occlusive dressing
Arm Title
Negative Pressure
Arm Type
Experimental
Arm Description
primary closure with gauze and adhesive/occlusive dressing under negative pressure
Intervention Type
Procedure
Intervention Name(s)
Needle-Aspirated Negative Pressure Dressing
Intervention Description
dressing consisting of Needle-Aspirated Negative Pressure dressing with gauze and adhesive/occlusive dressing, placed over wound after primary closure
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
dressing consisting of gauze and adhesive/occlusive dressing, placed over wound after primary closure
Primary Outcome Measure Information:
Title
Surgical Site Infection
Description
Surgical Site Infection
Time Frame
30 days post procedure
Secondary Outcome Measure Information:
Title
Rate of Wound Closure
Description
rate of wound closure at 3 weeks post procedure and 12 weeks post procedure
Time Frame
3 weeks post procedure and 12 weeks post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang W Lee, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be made available outside the study group.
Learn more about this trial
Needle-Aspirated Compression Dressing Following Ostomy Reversal
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