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

Irrimax

Status: Terminated

Conditions: Skin and Soft Tissue Infections; Abscess

Treatments: Device: Irrisept Delivery System; Device: Standard of Care (SoC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01076049

108527

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Standard of Care (SoC)

Active Comparator group

Description:

For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s).

Treatment:

Device: Standard of Care (SoC)

Irrisept

Active Comparator group

Description:

For subjects randomized to the investigational group, Irrisept was used.

Treatment:

Device: Irrisept Delivery System