Clinical trial NCT04957732: The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)
Official title: The Effect of Wound Irrigation With Irrisept Delivery System on Abscess Healing in Patients Presenting to the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abscess
Keywords: Wound Irrigation
Lead sponsor: Irrimax Corporation
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization methodology was controlled by the site.
Primary purpose: OTHER

Brief summary: 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.

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects That Used Oral Antibiotics
timeFrame: 24, 48, 72 & 96-hour visit intervals
measure: Abscess Wound Healing Determined By Wound Improvement Score
timeFrame: Abscess wound healing, assessed by wound improvement, was reviewed at the 48-hour visit.
measure: Abscess Wound Healing Determined By Exudation Score
timeFrame: Abscess wound healing, assessed by exudation, was reviewed at baseline and the 48-hour visit.
measure: Abscess Wound Healing Determined By Pain Score
timeFrame: Abscess wound healing, assessed by pain, was reviewed at baseline and the 48-hour visit.
Secondary outcomes:
measure: Oral Antibiotic Use Required, Determined By Erythema Area Size
timeFrame: The need for oral antibiotics, assessed by erythema, was reviewed at baseline and the 48-hour visit.
measure: Oral Antibiotic Use Required, Determined By Induration (Abscess Area Size)
timeFrame: 48-hours after baseline
measure: Oral Antibiotic Use Required Due To Warmth
timeFrame: The need for oral antibiotics, assessed by warmth, was reviewed at baseline and the 48-hour visit.
measure: Oral Antibiotic Use Required Due To Fluctuance
timeFrame: The need for oral antibiotics, assessed by fluctuance, was reviewed at baseline and the 48-hour visit.
Other outcomes:
measure: Oral Antibiotic Use Required Due To Results of MRSA/Wound Culture
timeFrame: 0 days
Locations:
city: Gainesville
country: United States
facility: University of Florida, Shands Emergency Department
state: Florida
Study officials:
affiliation: University of Florida/Shands Emergency Department
name: Richard Petrik, MD
role: PRINCIPAL_INVESTIGATOR
References: