Back to resultsThe Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF Study)
Primary Purpose
Skin and Soft Tissue Infections, Abscess
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care (SoC)
Irrisept Delivery System
Sponsored by
About this trial
This is an interventional other trial for Skin and Soft Tissue Infections
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Tampa General Hospital - University of South Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard of Care (SoC)
Irrisept
Arm Description
For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s).
For subjects randomized to the investigational group, Irrisept was used.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01076049
Brief Title
The Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Suboptimal Recruitment
Study Start Date
January 2010 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Irrimax Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Soft Tissue Infections, Abscess
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The randomization methodology was controlled by a biostatistician at the site.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care (SoC)
Arm Type
Active Comparator
Arm Description
For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s).
Arm Title
Irrisept
Arm Type
Active Comparator
Arm Description
For subjects randomized to the investigational group, Irrisept was used.
Intervention Type
Device
Intervention Name(s)
Standard of Care (SoC)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Irrisept Delivery System
Other Intervention Name(s)
Irrisept
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound State at 48-Hour Follow-up Visit
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Clinical Performance of Irrisept to the Current SoC
Description
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.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wein, MD
Organizational Affiliation
Tampa General Hospital, University South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital - University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF Study)
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