AbscessNCT01302548
The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department
A study testing IRRISEPT in people with Abscess, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine if wound cleansing and irrigation using the IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized stream, will improve the outcome for infected abscesses in patients that present in the emergency department. 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
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2012
- 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
- Patient must be able to answer questions and be medically stable as defined by the Emergency Department physician
- Patient must voluntarily participate in the study
- Exclusion Criteria:Patients with any of the following are excluded:
- Currently receiving antibiotics or received antibiotics within last 72 hours
- Evidence of systemic infection (fever, aches, chills, nausea)
Show all 16Show fewer
- 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, Crohns 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Hospital at the University of Florida
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 is to determine if wound cleansing and irrigation using the IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized stream, will improve the outcome for infected abscesses in patients that present in the emergency department.
- Conditions
- Abscess
- Being tested
- IRRISEPT, Usual Care
- Keywords
- Abscess, Wound Irrigation, Wound Debridement, Wound Healing, Incision and drainage, Chlorhexidine
- Medical subject headings
- Abscess, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRRISEPTDevice
Device containing sterile water and chlorhexidine gluconate (CHG)
Usual CareProcedure or surgery
Also called Saline irrigation, Incision & Drainage
The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
| Study group | Role | What they receive |
|---|---|---|
| IRRISEPT | Experimental | Device containing sterile water and chlorhexidine gluconate (CHG) Receives: Device: IRRISEPT |
| Usual Care | Active comparator | The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abscess Healing Based on Abscess Measurement Scale
The abscess healing process will use two methods: 1) "usual method" includes saline irrigation and/or incision \& drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler.
Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild
Measured: 48 hours
Secondary outcomes (2)
Number of Patients Prescribed Oral Antibiotics
Number of patients prescribed oral antibiotics
Measured: 48 hours
Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.
The Abscess Measurement Scale was measured using a centimeter ruler.
Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Study did not accrue the required number of study subjects.
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.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Sponsor
- Investigators
- Richard F Petrik, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302548
- Sponsor's protocol ID
- 20101227
- Status last verified
- Feb 2014
- First submitted
- 29 Sep 2010
- Last updated
- 7 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. 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
- NCT01302548
- Acronym / sponsor ID
- 20101227
- Conditions
- Abscess
- Keywords
- Abscess, Wound Irrigation, Wound Debridement, Wound Healing, Incision and drainage, Chlorhexidine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study did not accrue the required number of study subjects.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Irrimax Corporation
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Posted 7 Apr 2014
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 is to determine if wound cleansing and irrigation using the IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized stream, will improve the outcome for infected abscesses in patients that present in the emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRRISEPT | Experimental | Device: IRRISEPTDevice containing sterile water and chlorhexidine gluconate (CHG) |
| Usual Care | Active comparator | Procedure: Usual CareThe usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Immunocompetent individuals 12 years of age or older with an uncomplicated abscess
- Patient must be able to answer questions and be medically stable as defined by the Emergency Department physician
- Patient must voluntarily participate in the study
- Currently receiving antibiotics or received antibiotics within last 72 hours
- Evidence of systemic infection (fever, aches, chills, nausea)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IRRISEPTDevice containing sterile water and chlorhexidine gluconate (CHG) | Device | IRRISEPT |
| Usual CareAlso: Saline irrigation, Incision & DrainageThe usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. | Procedure or surgery | Usual Care |
Primary outcome
Abscess Healing Based on Abscess Measurement Scale
Time frame: 48 hours
The abscess healing process will use two methods: 1) "usual method" includes saline irrigation and/or incision \& drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler. Scale 8cm - 10cm = Severe 6cm - 8cm = Moderate/severe 4cm - 6cm = Moderate 2cm - 4cm = Mild/moderate 0cm - 2cm = Mild
2 secondary outcomes
Number of Patients Prescribed Oral Antibiotics
Time frame: 48 hours
Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 F Petrik, MD principal investigator
University of Florida
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 in people with Abscess, run by University of Florida 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 16 inclusion and 0 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 7 Apr 2014. 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 7 Apr 2014). 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?
Abscess Healing Based on Abscess Measurement Scale (time frame: 48 hours). 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 7 Apr 2014.