Not provided
Not provided
Not provided
Not provided
Not provided
Study did not accrue the required number of study subjects.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Irrimax Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRRISEPT | Experimental | Device containing sterile water and chlorhexidine gluconate (CHG) |
|
| Usual Care | Active Comparator | The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRRISEPT | Device | Device containing sterile water and chlorhexidine gluconate (CHG) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Prescribed Oral Antibiotics | Number of patients prescribed oral antibiotics | 48 hours |
| Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients. |
Not provided
Inclusion Criteria:
Exclusion Criteria:Patients with any of the following are excluded:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard F Petrik, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands Hospital at the University of Florida | Gainesville | Florida | 32610 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IRRISEPT | Device containing sterile water and chlorhexidine gluconate (CHG) |
| FG001 | Usual Care | The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IRRISEPT | Device containing sterile water and chlorhexidine gluconate (CHG) |
| BG001 | Usual Care | The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
|
02/26/2011 - 08/09/2012
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IRRISEPT | Device containing sterile water and chlorhexidine gluconate (CHG) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Pain | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment | Increased pain |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard F Petrik, MD | University of Florida | 352-265-5911 | rpetrik@ufl.edu |
Not provided
| ID | Term |
|---|---|
| D000038 | Abscess |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D004322 | Drainage |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual Care |
| Procedure |
The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. |
|
|
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
| 48 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Number of Patients Prescribed Oral Antibiotics | Number of patients prescribed oral antibiotics | Posted | Number | participants | 48 hours |
|
|
|
|
| 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 | Only participants that were MRSA-positive, were analyzed. | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
|
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Usual Care | The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion. | 0 | 19 | 0 | 19 |
|
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |