Abscess
Conditions
Keywords
Abscess, Wound Irrigation, Wound Debridement, Wound Healing, Incision and drainage, Chlorhexidine
Brief 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.
Interventions
DEVICEIRRISEPT
Device containing sterile water and chlorhexidine gluconate (CHG)
PROCEDUREUsual Care
The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
Sponsors
Irrimax Corporation
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abscess Healing Based on Abscess Measurement Scale | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Prescribed Oral Antibiotics | 48 hours | Number of patients prescribed oral antibiotics |
| Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients. | 48 hours | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IRRISEPT Device containing sterile water and chlorhexidine gluconate (CHG) | 14 |
| Usual Care The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. | 19 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Usual Care | IRRISEPT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 14 Participants | 31 Participants |
| Age, Continuous | 24.83 years STANDARD_DEVIATION 9.81 | 32.42 years STANDARD_DEVIATION 9.04 | 27.87 years STANDARD_DEVIATION 10.08 |
| Region of Enrollment United States | 19 participants | 14 participants | 33 participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 14 | 0 / 19 |
| serious Total, serious adverse events | 0 / 14 | 0 / 19 |
Outcome results
Primary
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
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IRRISEPT | Abscess Healing Based on Abscess Measurement Scale | 2.750 units on a scale | Standard Deviation 0.6216 |
| Usual Care | Abscess Healing Based on Abscess Measurement Scale | 2.833 units on a scale | Standard Deviation 0.9852 |
Comparison: Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power.p-value: 0.79795% CI: [-0.5738, 0.7405]t-test, 2 sided
Secondary
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
Time frame: 48 hours
Population: Only participants that were MRSA-positive, were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IRRISEPT | Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients. | 2.4 units on a scale | Standard Deviation 0.5477 |
| Usual Care | Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients. | 2.0 units on a scale | — |
Comparison: Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing in patients that are MRSA positive.~This study did not enroll an adequate number of patients to meet sufficient power.p-value: 0.541595% CI: [-2.0659, 1.2659]t-test, 2 sided
Secondary
Number of Patients Prescribed Oral Antibiotics
Number of patients prescribed oral antibiotics
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IRRISEPT | Number of Patients Prescribed Oral Antibiotics | 1 participants |
| Usual Care | Number of Patients Prescribed Oral Antibiotics | 5 participants |
Comparison: Ho: There is not a significant difference between the proportion of patients requiring antibiotics after the use of IRRISEPT solution vs. the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power.p-value: 0.357595% CI: [0.0239, 2.3394]Fisher Exact