Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage

This study has been completed.
Sponsor:
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

September 22, 2009
October 27, 2010
March 2008
September 2009   (final data collection date for primary outcome measure)
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.
Surface area of abscess [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00984022 on ClinicalTrials.gov Archive Site
  • 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.
  • Patient rating of pain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Surface area of cellulitis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage
Aquacel vs. Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage: A Randomized Control Study

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Abscess
  • Cellulitis
  • Device: Type of dressing - Iodoform
    Dressing for packing a cutaneous abscess
    Other Name: Iodoform
  • Device: Type of dressing - Aquacel
    Aquacel dressing
    Other Name: Aquacel
  • Active Comparator: Iodoform dressing
    Iodoform dressing for cutaneous abscess
    Intervention: Device: Type of dressing - Iodoform
  • Active Comparator: Aquacel dressing
    Aquacel dressing for cutaneous abscess
    Intervention: Device: Type of dressing - Aquacel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00984022
2008-003
Yes
Madhumita Sinha, MD, District Medical Group
Maricopa Integrated Health System
Not Provided
Principal Investigator: Madhumita Sinha, MD District Medical Group
Maricopa Integrated Health System
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP