Skin and Soft Tissue InfectionsNCT01076049
The Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF Study)
A study testing Irrisept Delivery System in people with Skin and Soft Tissue Infections and Abscess, run by Irrimax Corporation at 1 site in United States.
Trial summary
The purpose of this study was to determine whether Irrisept can effectively prevent the progression of skin and soft tissue infections (SSTIs) as compared to treatment by the current Standard of Care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Skin and Soft Tissue Infections, Abscess
- What is being tested?
- Irrisept Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80
- Skin and soft tissue infections (SSTIs), in the form of an abscess, which will require incision and drainage.
- Patient able to provide an informed consent.
- Patient volunteers to participate.
Who cannot join
- Wound was caused by human or animal bite.
- Wound is a blunt crush injury or has tendon, bone, or joint involvement.
- Diabetic foot infection.
- Anticipated incision size less than 5mm.
- Abscess extends to the muscle layer.
- Admission to hospital for any reason, including IV antibiotics.
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- Clinical signs of systemic infection on initial patient encounter.
- Prior history of allergy or hypersensitivity to CHG.
- Neutropenic (known ANC<500/mm3), HIV (known CD4<50), or other severely immunocompromised state (e.g., receiving chemotherapy).
- Patient is diagnosed with systemic lupus erythematosus or other immunological disease.
- Currently in police custody.
- Patient withdraws from participation.
- Patient unable or unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tampa General Hospital - University of South Florida
Tampa, Florida, 33606
About this study
Official title: Evaluation of a Novel Solution, IrriSept, a New Delivery System, Containing a Long-acting Antimicrobial Agent for Irrigation of Skin and Soft Tissue Infections, in the Form of an Abscess in the Emergency Department: a Pilot Study
The purpose of this study was to determine whether Irrisept can effectively prevent the progression of skin and soft tissue infections (SSTIs) as compared to treatment by the current Standard of Care.
Read the detailed description
After being informed about the trial and potential risks, subjects completed an informed consent form prior to participation. After eligibility criteria was verified, an initial wound assessment examination was performed. Subjects were then randomized to the Irrisept or Standard of Care treatment group. Forty-eight hours later, wound progression and signs of infection were assessed.
- Conditions
- Skin and Soft Tissue Infections, Abscess
- Being tested
- Standard of Care (SoC), Irrisept Delivery System
- Medical subject headings
- Soft Tissue Infections, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SoC)Device
The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits.
Irrisept Delivery SystemDevice
Also called Irrisept
Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression.
Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) | Active comparator | For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s). Receives: Device: Standard of Care (SoC) |
| Irrisept | Active comparator | For subjects randomized to the investigational group, Irrisept was used. Receives: Device: Irrisept Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound State at 48-Hour Follow-up Visit
The primary endpoint was overall wound progression and signs of infection 48 hours post-treatment. This was measured via a blinded investigator's discretion and recorded as 'improved', 'no change', 'progression of signs or symptoms of infection', or 'immediate treatment required' if an infection had progressed to a certain extent.
Measured: 48 hours
Secondary outcomes (1)
Clinical Performance of Irrisept to the Current SoC
The study tracked any instance of a subject's conditions worsening compared to their baseline measurements. This included a worsening in the size (length and width) and clinical signs (erythema, area, induration, tenderness, warm, pain, cellulitis and other) of the infection.
While the protocol states the overall prevalence of Methicillin-resistant Staphylococcus Aureus (MRSA) colonization is the secondary objective, this information was not collected by the site. Therefore, worsening of clinical outcomes is considered the secondary objective.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Suboptimal Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin and Soft Tissue InfectionsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization methodology was controlled by a biostatistician at the site.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irrimax Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wein, MD, Principal investigator, Tampa General Hospital, University South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076049
- Sponsor's protocol ID
- 108527
- Status last verified
- Aug 2021
- First submitted
- 23 Feb 2010
- Last updated
- 23 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Solution, IrriSept, a New Delivery System, Containing a Long-acting Antimicrobial Agent for Irrigation of Skin and Soft Tissue Infections, in the Form of an Abscess in the Emergency Department: a Pilot Study
- ClinicalTrials.gov ID
- NCT01076049
- Acronym / sponsor ID
- 108527
- Conditions
- Skin and Soft Tissue Infections, Abscess
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suboptimal Recruitment
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Irrimax CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Posted 28 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine whether Irrisept can effectively prevent the progression of skin and soft tissue infections (SSTIs) as compared to treatment by the current Standard of Care.
Detailed description
After being informed about the trial and potential risks, subjects completed an informed consent form prior to participation. After eligibility criteria was verified, an initial wound assessment examination was performed. Subjects were then randomized to the Irrisept or Standard of Care treatment group. Forty-eight hours later, wound progression and signs of infection were assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization methodology was controlled by a biostatistician at the site.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | Active comparator | Device: Standard of Care (SoC)For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s). |
| Irrisept | Active comparator | Device: Irrisept Delivery SystemFor subjects randomized to the investigational group, Irrisept was used. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80
- Skin and soft tissue infections (SSTIs), in the form of an abscess, which will require incision and drainage.
- Patient able to provide an informed consent.
- Patient volunteers to participate.
Key exclusion criteria (13 listed)
- Wound was caused by human or animal bite.
- Wound is a blunt crush injury or has tendon, bone, or joint involvement.
- Diabetic foot infection.
- Anticipated incision size less than 5mm.
- Abscess extends to the muscle layer.
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 |
|---|---|---|
| Standard of Care (SoC)The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits. | Device | Standard of Care (SoC) |
| Irrisept Delivery SystemAlso: IrriseptIrrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits. | Device | Irrisept |
Primary outcome
Wound State at 48-Hour Follow-up Visit
Time frame: 48 hours
The primary endpoint was overall wound progression and signs of infection 48 hours post-treatment. This was measured via a blinded investigator's discretion and recorded as 'improved', 'no change', 'progression of signs or symptoms of infection', or 'immediate treatment required' if an infection had progressed to a certain extent.
1 secondary outcome
Clinical Performance of Irrisept to the Current SoC
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David Wein, MD principal investigator
Tampa General Hospital, University South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrisept Delivery System in people with Skin and Soft Tissue Infections and Abscess, run by Irrimax Corporation 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 4 inclusion and 13 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: stopped early, as of the sponsor's last update on 23 Aug 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound State at 48-Hour Follow-up Visit (time frame: 48 hours). 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 23 Aug 2021.