AbscessNCT04957732
The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)
A study testing Irrisept Delivery System in people with Abscess, run by Irrimax Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Abscess
- What is being tested?
- Irrisept Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Shands Emergency Department
Gainesville, Florida, 32610
About this study
Official title: 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.
Read the 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.
- Conditions
- Abscess
- Being tested
- Standard of Care (SoC), Irrisept Delivery System
- Keywords
- Wound Irrigation
- Medical subject headings
- Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SoC)Device
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.
Irrisept Delivery SystemDevice
Also called Irrisept
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) | Active comparator | For subjects randomized to the control group, Standard of Care (SoC), which was normal saline, was used. Receives: Device: Standard of Care (SoC) |
| Irrisept | Active comparator | For subjects randomized to the investigational group, Irrisept was used. Receives: Device: Irrisept Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Abscess wound healing, assessed by pain, was reviewed at baseline and the 48-hour visit.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The need for oral antibiotics, assessed by fluctuance, was reviewed at baseline and the 48-hour visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study startJan 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Research facility was restructured and no longer treated subjects in the study population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization methodology was controlled by the site.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irrimax Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Petrik, MD, Principal investigator, University of Florida/Shands Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957732
- Sponsor's protocol ID
- 20101227
- Status last verified
- Jan 2022
- First submitted
- 14 Jun 2021
- Last updated
- 2 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wound Irrigation With Irrisept Delivery System on Abscess Healing in Patients Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT04957732
- Acronym / sponsor ID
- 20101227
- Conditions
- Abscess
- Keywords
- Wound Irrigation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research facility was restructured and no longer treated subjects in the study population.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Irrimax CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2010 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 2 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization methodology was controlled by the site.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | Active comparator | Device: Standard of Care (SoC)For subjects randomized to the control group, Standard of Care (SoC), which was normal saline, was used. |
| Irrisept | Active comparator | Device: Irrisept Delivery SystemFor subjects randomized to the investigational group, Irrisept was used. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Immunocompetent individuals, 12 years of age or older with an uncomplicated abscess
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Standard of Care (SoC) |
| Irrisept Delivery SystemAlso: IrriseptIrrisept 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. | Device | Irrisept |
Primary outcome
Number of Subjects That Used Oral Antibiotics
Time frame: 24, 48, 72 & 96-hour visit intervals
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
Time frame: Abscess wound healing, assessed by wound improvement, was reviewed at the 48-hour visit.
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
Time frame: Abscess wound healing, assessed by exudation, was reviewed at baseline and the 48-hour visit.
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
Time frame: Abscess wound healing, assessed by pain, was reviewed at baseline and the 48-hour visit.
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.
4 secondary outcomes
Oral Antibiotic Use Required, Determined By Erythema Area Size
Time frame: 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)
Time frame: 48-hours after baseline
Oral Antibiotic Use Required Due To Warmth
Time frame: The need for oral antibiotics, assessed by warmth, was reviewed at baseline and the 48-hour visit.
Oral Antibiotic Use Required Due To Fluctuance
Time frame: The need for oral antibiotics, assessed by fluctuance, was reviewed at baseline and the 48-hour visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Petrik, MD principal investigator
University of Florida/Shands Emergency Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrisept Delivery System in people with Abscess, run by Irrimax Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects That Used Oral Antibiotics (time frame: 24, 48, 72 & 96-hour visit intervals). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.