Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage
This study has been completed.
Sponsor:
Maricopa Integrated Health System
Information provided by:
Maricopa Integrated Health System
ClinicalTrials.gov Identifier:
NCT00984022
First received: September 22, 2009
Last updated: October 27, 2010
Last verified: October 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Abscess Cellulitis |
Device: Type of dressing - Iodoform Device: Type of dressing - Aquacel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aquacel vs. Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage: A Randomized Control Study |
Resource links provided by NLM:
Further study details as provided by Maricopa Integrated Health System:
Primary Outcome Measures:
- Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]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 Outcome Measures:
- Change in Patient Rating of Pain [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 92 |
| Study Start Date: | March 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Iodoform dressing
Iodoform dressing for cutaneous abscess
|
Device: Type of dressing - Iodoform
Dressing for packing a cutaneous abscess
Other Name: Iodoform
|
|
Active Comparator: Aquacel dressing
Aquacel dressing for cutaneous abscess
|
Device: Type of dressing - Aquacel
Aquacel dressing
Other Name: Aquacel
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984022
Locations
| United States, Arizona | |
| Maricopa Integrated Health System | |
| Phoenix, Arizona, United States, 85008 | |
Sponsors and Collaborators
Maricopa Integrated Health System
Investigators
| Principal Investigator: | Madhumita Sinha, MD | District Medical Group |
More Information
No publications provided
| Responsible Party: | Madhumita Sinha, MD, District Medical Group |
| ClinicalTrials.gov Identifier: | NCT00984022 History of Changes |
| Other Study ID Numbers: | 2008-003 |
| Study First Received: | September 22, 2009 |
| Results First Received: | August 11, 2010 |
| Last Updated: | October 27, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Maricopa Integrated Health System:
|
abscess MRSA Aquacel dressing Iodoform dressing |
Additional relevant MeSH terms:
|
Abscess Cellulitis Suppuration Infection Inflammation Pathologic Processes Skin Diseases, Infectious |
Connective Tissue Diseases Carboxymethylcellulose Sodium Laxatives Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013