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

Not Applicable

Terminated

Interventions: Device: Standard of Care (SoC)
Device: Irrisept Delivery System

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Standard of Care (SoC)	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	Irrisept Delivery System	For subjects randomized to the investigational group, Irrisept was used.

Primary Outcome Measures

Name	Time	Method
Wound State at 48-Hour Follow-up Visit	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Performance of Irrisept to the Current SoC	48 hours	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.