Back to resultsThe Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)
Primary Purpose
Abscess
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care (SoC)
Irrisept Delivery System
Sponsored by
About this trial
This is an interventional other trial for Abscess focused on measuring Wound Irrigation
Eligibility Criteria
Inclusion Criteria:
Immunocompetent individuals, 12 years of age or older with an uncomplicated abscess
- Uncomplicated abscess is defined as ≤8 cm of induration (defined as firmness to touch) at the greatest diameter.
- ≤4 cm of surrounding erythema (surrounding redness).
- Defined area of central fluctuance may or may not be present.
- Patient must be able to answer questions.
- Patient must be medically stable as defined by the emergency department physician.
- Patient must participate voluntarily in the study.
Exclusion Criteria:
- Currently receiving antibiotics or received antibiotics within the last 72 hours.
- Evidence of systemic infection (fever, aches, chills, nausea).
- Requires admission to the hospital for infection or for any other reason(s).
- Abscess caused by a human or animal bite.
- Prior history of hypersensitivity or allergy to Chlorhexidine Gluconate (CHG).
- Immunodeficiency (examples: HIV positive, Crohn's disease, systemic lupus erythematosus, Addison's disease, psoriasis, splenectomy, leukemia, cancer (on chemotherapy)).
- Currently on any immune-modifying medication (examples - prednisone, antivirals).
- History of chronic skin infection (3 or more in the past year).
- Chronic medical problem (for example, end-stage heart, liver, kidney or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant).
- Mental illness, including but not limited to, substance abuse, dementia, schizophrenia or mentally handicapped or challenged.
- Incarcerated.
- Patient is pregnant or thinks she may be pregnant.
Sites / Locations
- University of Florida, Shands Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard of Care (SoC)
Irrisept
Arm Description
For subjects randomized to the control group, Standard of Care (SoC), which was normal saline, was used.
For subjects randomized to the investigational group, Irrisept was used.
Outcomes
Primary Outcome Measures
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).
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 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 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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04957732
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Research facility was restructured and no longer treated subjects in the study population.
Study Start Date
January 2010 (Actual)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Irrimax Corporation
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess
Keywords
Wound Irrigation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The randomization methodology was controlled by the site.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care (SoC)
Arm Type
Active Comparator
Arm Description
For subjects randomized to the control group, Standard of Care (SoC), which was normal saline, was used.
Arm Title
Irrisept
Arm Type
Active Comparator
Arm Description
For subjects randomized to the investigational group, Irrisept was used.
Intervention Type
Device
Intervention Name(s)
Standard of Care (SoC)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Irrisept Delivery System
Other Intervention Name(s)
Irrisept
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects That Used Oral Antibiotics
Description
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).
Time Frame
24, 48, 72 & 96-hour visit intervals
Title
Abscess Wound Healing Determined By Wound Improvement Score
Description
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.
Time Frame
Abscess wound healing, assessed by wound improvement, was reviewed at the 48-hour visit.
Title
Abscess Wound Healing Determined By Exudation Score
Description
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.
Time Frame
Abscess wound healing, assessed by exudation, was reviewed at baseline and the 48-hour visit.
Title
Abscess Wound Healing Determined By Pain Score
Description
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.
Time Frame
Abscess wound healing, assessed by pain, was reviewed at baseline and the 48-hour visit.
Secondary Outcome Measure Information:
Title
Oral Antibiotic Use Required, Determined By Erythema Area Size
Description
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.
Time Frame
The need for oral antibiotics, assessed by erythema, was reviewed at baseline and the 48-hour visit.
Title
Oral Antibiotic Use Required, Determined By Induration (Abscess Area Size)
Description
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.
Time Frame
48-hours after baseline
Title
Oral Antibiotic Use Required Due To Warmth
Description
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.
Time Frame
The need for oral antibiotics, assessed by warmth, was reviewed at baseline and the 48-hour visit.
Title
Oral Antibiotic Use Required Due To Fluctuance
Description
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.
Time Frame
The need for oral antibiotics, assessed by fluctuance, was reviewed at baseline and the 48-hour visit.
Other Pre-specified Outcome Measures:
Title
Oral Antibiotic Use Required Due To Results of MRSA/Wound Culture
Description
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.
Time Frame
0 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Immunocompetent individuals, 12 years of age or older with an uncomplicated abscess
Uncomplicated abscess is defined as ≤8 cm of induration (defined as firmness to touch) at the greatest diameter.
≤4 cm of surrounding erythema (surrounding redness).
Defined area of central fluctuance may or may not be present.
Patient must be able to answer questions.
Patient must be medically stable as defined by the emergency department physician.
Patient must participate voluntarily in the study.
Exclusion Criteria:
Currently receiving antibiotics or received antibiotics within the last 72 hours.
Evidence of systemic infection (fever, aches, chills, nausea).
Requires admission to the hospital for infection or for any other reason(s).
Abscess caused by a human or animal bite.
Prior history of hypersensitivity or allergy to Chlorhexidine Gluconate (CHG).
Immunodeficiency (examples: HIV positive, Crohn's disease, systemic lupus erythematosus, Addison's disease, psoriasis, splenectomy, leukemia, cancer (on chemotherapy)).
Currently on any immune-modifying medication (examples - prednisone, antivirals).
History of chronic skin infection (3 or more in the past year).
Chronic medical problem (for example, end-stage heart, liver, kidney or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant).
Mental illness, including but not limited to, substance abuse, dementia, schizophrenia or mentally handicapped or challenged.
Incarcerated.
Patient is pregnant or thinks she may be pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Petrik, MD
Organizational Affiliation
University of Florida/Shands Emergency Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida, Shands Emergency Department
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)
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