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

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.

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.

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.