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This study compares Aquacel against routine Iodoform packing for packing abscess cavities after incision and drainage. It is hypothesized that Aquacel will produce speedier healing of the abscess.
The large increase in the incidence of skin and soft tissue infections cause by methicillin resistant staphylococcus aureus (MRSA) has produced a corresponding increase in the number of ED patients presenting with abscesses that require incision and drainage. This study compares Aquacel against routine Iodoform packing for packing abscess cavities after incision and drainage. It is hypothesized that Aquacel will produce speedier healing of the abscess. More effective abscess healing will reduce the need for oral antibiotic coverage, which will in turn reduce the potential for drug resistance caused by indiscriminate use of oral antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodoform dressing | Active Comparator | Iodoform dressing for cutaneous abscess |
|
| Aquacel dressing | Active Comparator | Aquacel dressing for cutaneous abscess |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type of dressing - Iodoform | Device | Dressing for packing a cutaneous abscess |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess | Participants were assessed to see whether or not the surface area of the abscess was reduced by at least 30%, and the number of such participants is reported. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Rating of Pain | Change in mean pain score based on patient self-report, using Wong-Baker FACES pain rating scale. Scale ranges from 0 to 5, where 5 means the worst pain possible and 0 means no pain at all. | Baseline and 2 weeks |
| Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhumita Sinha, MD | District Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Integrated Health System | Phoenix | Arizona | 85008 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iodoform Dressing | Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage. |
| FG001 | Aquacel Dressing | Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iodoform Dressing | Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage. |
| BG001 | Aquacel Dressing |
| 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 | Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess | Participants were assessed to see whether or not the surface area of the abscess was reduced by at least 30%, and the number of such participants is reported. | Posted | Number | Participants | 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iodoform Dressing | Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Drachman | Maricopa Integrated Health System | 602-344-5161 | david.drachman@mihs.org |
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| ID | Term |
|---|---|
| D000038 | Abscess |
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Aquacel vs. Iodoform Gauze
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| Type of dressing - Aquacel | Device | Aquacel dressing |
|
|
Participants were assessed to see whether or not the surface area of the cellulitis was reduced by at least 30% and the number of such participants was reported. |
| 2 weeks |
Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
| 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 | Change in Patient Rating of Pain | Change in mean pain score based on patient self-report, using Wong-Baker FACES pain rating scale. Scale ranges from 0 to 5, where 5 means the worst pain possible and 0 means no pain at all. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 2 weeks |
|
|
|
|
| Secondary | Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis. | Participants were assessed to see whether or not the surface area of the cellulitis was reduced by at least 30% and the number of such participants was reported. | Posted | Number | Participants | 2 weeks |
|
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Aquacel Dressing | Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage. | 0 | 49 | 0 | 49 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012874 | Skin Diseases, Infectious |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |