Abscess, Cellulitis
Conditions
Keywords
abscess, MRSA, Aquacel dressing, Iodoform dressing
Brief summary
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.
Detailed description
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.
Interventions
DEVICEType of dressing - Iodoform
Dressing for packing a cutaneous abscess
DEVICEType of dressing - Aquacel
Aquacel dressing
Sponsors
Valleywise Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Aquacel vs. Iodoform Gauze
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* presenting to Maricopa Medical Center ED with cutaneous abscess requiring incision and drainage
Exclusion criteria
* known sensitivity to Aquacel * pregnant, nursing, or expecting to become pregnant * incarcerated patient * prior treatment of same abscess with incision and drainage * multiple abscesses * immunodeficiency * facial abscess * suspected osteomyelitis or septic arthritis * diabetic foot, decubitis, or ischaemic ulcers * unable to provide informed consent or assent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Rating of Pain | Baseline and 2 weeks | 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. |
| Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis. | 2 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| Aquacel Dressing Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage. | 49 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 14 |
Baseline characteristics
| Characteristic | Aquacel Dressing | Iodoform Dressing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 43 Participants | 92 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 11.6 | 36.8 years STANDARD_DEVIATION 12.6 | 38.0 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 49 participants | 43 participants | 92 participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 33 Participants | 28 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 49 |
| serious Total, serious adverse events | 0 / 43 | 0 / 49 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iodoform Dressing | Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess | 6 Participants |
| Aquacel Dressing | Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess | 19 Participants |
Comparison: The percentages achieving 30% or greater reduction in the surface area of the abscess were compared with Fisher's exact test.p-value: 0.0003Fisher Exact
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.
Time frame: Baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iodoform Dressing | Change in Patient Rating of Pain | -1.23 Scores on a scale | Standard Deviation 1.89 |
| Aquacel Dressing | Change in Patient Rating of Pain | -1.82 Scores on a scale | Standard Deviation 1.73 |
Comparison: Repeated measures ANOVA using 2 X 2 factorial design, with one between-subjects factor (Group) and one within-subjects factor (Time). Null hypothesis is: The type of dressing does not affect patient pain ratings.p-value: 0.043ANOVA
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.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iodoform Dressing | Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis. | 13 Participants |
| Aquacel Dressing | Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis. | 13 Participants |
Comparison: Fisher's exact test was used to compare the percentage of individuals achieving a 30% or greater reduction in cellulitis surface area between the Iodoform and Aquacel groups.p-value: 0.847Fisher Exact