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

The Effect of Wound Irrigation With Irrisept Delivery System on Abscess Healing in Patients Presenting to the Emergency Department

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.

Study Overview

• Status: Terminated
• Conditions: Abscess
• Intervention / Treatment: Device: Standard of Care (SoC); Device: Irrisept Delivery System

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida, Shands Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Irrisept; For subjects randomized to the investigational group, Irrisept was used.	Device: Irrisept Delivery System; Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. The device had an option for use with an Irriprobe applicator or an abscess irrigation tip. Irrisept was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.; Other Names: Irrisept
Active Comparator: Standard of Care (SoC); For subjects randomized to the control group, Standard of Care (SoC), which was normal saline, was used.	Device: Standard of Care (SoC); SoC consisted of irrigation with normal saline, using the same proprietary abscess irrigation tip as the Irrisept arm. SoC was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects That Used Oral Antibiotics	Oral antibiotic use was used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline).	24, 48, 72 & 96-hour visit intervals
Abscess Wound Healing Determined By Wound Improvement Score	Wound improvement assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Wound improvement was assessed via a clinician's discretion, according to a 5-point Likert scale: 1 = clinically resolved, no signs of active infection; 2 = markedly improved, resolving infection and healing; 3 = improved with some remaining signs of active infection; 4 = unchanged, stable without signs of worsening clinical infection and; 5 = worsening conditions. The results are shown using a chi-squared test, as an average Likert score compared between the 2 arms.	Abscess wound healing, assessed by wound improvement, was reviewed at the 48-hour visit.
Abscess Wound Healing Determined By Exudation Score	Exudation assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Exudation was assessed via a clinician's discretion, according to a 5-point Likert scale: 1 = none; 2 = scant; 3 = minimal; 4 = moderate and; 5 = copious. The results are shown using a chi-squared test to compare the means at baseline and 48-hours. A two-tailed t-test was conducted for the mean improvement.	Abscess wound healing, assessed by exudation, was reviewed at baseline and the 48-hour visit.
Abscess Wound Healing Determined By Pain Score	Pain assessments were used to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing when compared to pressurized irrigation with SoC (normal saline). Pain was assessed using a Visual Analogue Scale (VAS). The scale was measured in centimeters (cm) which ranged between 0 cm ("no pain" at the far left) to 9.5 cm ("most severe pain" at the far right). Subjects marked their pain rating on the scale with an "X". The distance from the beginning of the scale (far left) to the "X" was measured in cm. The mean VAS score was assessed at baseline and at the 48-hour follow-up visit. The overall mean improvement was compared between the 2 arms using two-tailed t-tests.	Abscess wound healing, assessed by pain, was reviewed at baseline and the 48-hour visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Antibiotic Use Required, Determined By Erythema Area Size	Erythema was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. The mean circumference of the erythema area, measured in centimeters (cm), was assessed at baseline and 48-hours later. This was performed by the clinician drawing a circle with a marker around the area of redness surrounding the abscess. Mean improvement was compared between the 2 arms using two-tailed t-tests.	The need for oral antibiotics, assessed by erythema, was reviewed at baseline and the 48-hour visit.
Oral Antibiotic Use Required, Determined By Induration (Abscess Area Size)	Induration or abscess size was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. The need for oral antibiotics, assessed by the mean induration or abscess size (measured in cm), was reviewed at baseline and the 48-hour visit. Mean improvement was compared between the 2 arms using two-tailed t-tests.	48-hours after baseline
Oral Antibiotic Use Required Due To Warmth	Warmth was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. Clinicians recorded whether the abscess was warm for each subject initially and after 48 hours.	The need for oral antibiotics, assessed by warmth, was reviewed at baseline and the 48-hour visit.
Oral Antibiotic Use Required Due To Fluctuance	The presence of fluctuance was assessed to determine if the use of Irrisept reduced or eliminated the need for oral antibiotics in uncomplicated abscesses. Clinicians recorded whether fluctuance was present for each subject initially and after 48 hours.	The need for oral antibiotics, assessed by fluctuance, was reviewed at baseline and the 48-hour visit.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Antibiotic Use Required Due To Results of MRSA/Wound Culture	The tertiary objective was to determine if the use of pressurized irrigation with Irrisept in uncomplicated abscesses improved wound healing in patients that have MRSA-positive wounds compared to pressurized irrigation with normal saline. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed. To be compliant with the CT.gov template, although the information is incorrect and no data was captured this outcome, data was entered for Irrisept subjects.	0 days

Collaborators and Investigators

• Sponsor: Irrimax Corporation
• Investigators: Principal Investigator: Richard Petrik, MD, University of Florida/Shands Emergency Department

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Wound Irrigation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: 20101227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes