Colostomy StomaPhase 3NCT03703661
Needle-Aspirated Compression Dressing Following Ostomy Reversal
A Phase 3 study testing Needle-Aspirated Negative Pressure Dressing in people with Colostomy Stoma and Ileostomy - Stoma, run by University of Southern California at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colostomy Stoma, Ileostomy - Stoma, Surgical Site Infection
- What is being tested?
- Needle-Aspirated Negative Pressure Dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2017to 1 Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- presence of a loop or end colostomy or ileostomy
- consenting to study and to ostomy reversal
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Can a Low Cost, Simple Needle-Aspirated Compression Dressing Reduce Surgical Site Infection Rates of Primarily Closed Ileostomy and Colostomy Reversal Wounds?
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.
Read the 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.
- Being tested
- Needle-Aspirated Negative Pressure Dressing, Control
- Keywords
- negative pressure wound therapy
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle-Aspirated Negative Pressure DressingProcedure or surgery
dressing consisting of Needle-Aspirated Negative Pressure dressing with gauze and adhesive/occlusive dressing, placed over wound after primary closure
ControlProcedure or surgery
dressing consisting of gauze and adhesive/occlusive dressing, placed over wound after primary closure
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | primary closure with gauze and adhesive/occlusive dressing Receives: Procedure: Control |
| Negative Pressure | Experimental | primary closure with gauze and adhesive/occlusive dressing under negative pressure Receives: Procedure: Needle-Aspirated Negative Pressure Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
Surgical Site Infection
Measured: 30 days post procedure
Secondary outcomes (1)
Rate of Wound Closure
rate of wound closure at 3 weeks post procedure and 12 weeks post procedure
Measured: 3 weeks post procedure and 12 weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start27 Aug 2017
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Won Lee, University of Southern California
- Investigators
- Sang W Lee, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703661
- Sponsor's protocol ID
- HS-16-00812
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available outside the study group.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Low Cost, Simple Needle-Aspirated Compression Dressing Reduce Surgical Site Infection Rates of Primarily Closed Ileostomy and Colostomy Reversal Wounds?
- ClinicalTrials.gov ID
- NCT03703661
- Acronym / sponsor ID
- HS-16-00812
- Keywords
- negative pressure wound therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 27 Aug 2017 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: Controlprimary closure with gauze and adhesive/occlusive dressing |
| Negative Pressure | Experimental | Procedure: Needle-Aspirated Negative Pressure Dressingprimary closure with gauze and adhesive/occlusive dressing under negative pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- presence of a loop or end colostomy or ileostomy
- consenting to study and to ostomy reversal
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle-Aspirated Negative Pressure Dressingdressing consisting of Needle-Aspirated Negative Pressure dressing with gauze and adhesive/occlusive dressing, placed over wound after primary closure | Procedure or surgery | Negative Pressure |
| Controldressing consisting of gauze and adhesive/occlusive dressing, placed over wound after primary closure | Procedure or surgery | Control |
Primary outcome
Surgical Site Infection
Time frame: 30 days post procedure
Surgical Site Infection
1 secondary outcome
Rate of Wound Closure
Time frame: 3 weeks post procedure and 12 weeks post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: No. IPD will not be made available outside the study group.
Related trials for Colostomy Stoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang W Lee, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Needle-Aspirated Negative Pressure Dressing in people with Colostomy Stoma and Ileostomy - Stoma, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 30 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.