Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage
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| Tracking Information | |||||
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| First Received Date ICMJE | September 22, 2009 | ||||
| Last Updated Date | October 27, 2010 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Surface area of abscess [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00984022 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage | ||||
| Official Title ICMJE | Aquacel vs. Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage: A Randomized Control Study | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 92 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00984022 | ||||
| Other Study ID Numbers ICMJE | 2008-003 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Madhumita Sinha, MD, District Medical Group | ||||
| Study Sponsor ICMJE | Maricopa Integrated Health System | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Maricopa Integrated Health System | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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