The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)

Irrimax

Status: Terminated

Conditions: Abscess

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04957732

20101227

Details and patient eligibility

About

The purpose of this study was to evaluate the safety and effectiveness of Irrisept compared to standard of care treatment of skin and soft tissue infections in the form of abscesses.

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. At intervals of 48 hours (up to 96 hours) later, abscesses were assessed until healing occurred. If the subject required antibiotics, this was recorded, as well as results from the wound and Methicillin-resistant Staphylococcus Aureus (MRSA) cultures.

Enrollment: 35 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Immunocompetent individuals, 12 years of age or older with an uncomplicated abscess

   1. Uncomplicated abscess is defined as ≤8 cm of induration (defined as firmness to touch) at the greatest diameter.
   2. ≤4 cm of surrounding erythema (surrounding redness).

2. Defined area of central fluctuance may or may not be present.

3. Patient must be able to answer questions.

4. Patient must be medically stable as defined by the emergency department physician.

5. Patient must participate voluntarily in the study.

Exclusion criteria

1. Currently receiving antibiotics or received antibiotics within the last 72 hours.
2. Evidence of systemic infection (fever, aches, chills, nausea).
3. Requires admission to the hospital for infection or for any other reason(s).
4. Abscess caused by a human or animal bite.
5. Prior history of hypersensitivity or allergy to Chlorhexidine Gluconate (CHG).
6. Immunodeficiency (examples: HIV positive, Crohn's disease, systemic lupus erythematosus, Addison's disease, psoriasis, splenectomy, leukemia, cancer (on chemotherapy)).
7. Currently on any immune-modifying medication (examples - prednisone, antivirals).
8. History of chronic skin infection (3 or more in the past year).
9. Chronic medical problem (for example, end-stage heart, liver, kidney or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant).
10. Mental illness, including but not limited to, substance abuse, dementia, schizophrenia or mentally handicapped or challenged.
11. Incarcerated.
12. Patient is pregnant or thinks she may be pregnant.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Standard of Care (SoC)

Active Comparator group

Description:

For subjects randomized to the control group, Standard of Care (SoC), which was normal saline, was used.

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