The Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF Study)

Study Overview
=================
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.

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

Conditions
-----------------
Abscess, Skin and Soft Tissue Infections

Intervention / Treatment
-----------------
* Device: Standard of Care (SoC)
* Device: Irrisept Delivery System


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomization methodology was controlled by a biostatistician at the site.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care (SoC)<br>For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s). | Device: Standard of Care (SoC)<br>* 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.<br>|
| Active Comparator: Irrisept<br>For subjects randomized to the investigational group, Irrisept was used. | Device: Irrisept Delivery System<br>* 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.<br>* Other names: Irrisept;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48 hours |