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

Irrimax Corporation114 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

114

Conditions

Skin and Soft Tissue Infections Abscess

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 to 80 2. Skin and soft tissue infections (SSTIs), in the form of an abscess, which will require incision and drainage. 3. Patient able to provide an informed consent. 4. Patient volunteers to participate. Exclusion Criteria: 1. Wound was caused by human or animal bite. 2. Wound is a blunt crush injury or has tendon, bone, or joint involvement. 3. Diabetic foot infection. 4. Anticipated incision size less than 5mm. 5. Abscess extends to the muscle layer. 6. Admission to hospital for any reason, including IV antibiotics. 7. Clinical signs of systemic infection on initial patient encounter. 8. Prior history of allergy or hypersensitivity to CHG. 9. Neutropenic (known ANC\<500/mm3), HIV (known CD4\<50), or other severely immunocompromised state (e.g., receiving chemotherapy). 10. Patient is diagnosed with systemic lupus erythematosus or other immunological disease. 11. Currently in police custody. 12. Patient withdraws from participation. 13. Patient unable or unwilling to give informed consent.

Locations (1)

Tampa General Hospital - University of South Florida

Tampa, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 48 hours

Secondary Outcomes

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.

Time frame: 48 hours

Data from ClinicalTrials.gov

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