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

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ClinicalTrials.gov Identifier: NCT00984022
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : October 27, 2010
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Maricopa Integrated Health System

Tracking Information
First Submitted Date  ICMJE September 22, 2009
First Posted Date  ICMJE September 24, 2009
Results First Submitted Date  ICMJE August 11, 2010
Results First Posted Date  ICMJE October 27, 2010
Last Update Posted Date October 4, 2017
Study Start Date  ICMJE March 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
Surface area of abscess [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT00984022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
  • Change in Patient Rating of Pain [ Time Frame: 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. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
  • Patient rating of pain [ Time Frame: 2 weeks ]
  • Surface area of cellulitis [ Time Frame: 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Aquacel vs. Iodoform Gauze
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Abscess
  • Cellulitis
Intervention  ICMJE
  • Device: Type of dressing - Iodoform
    Dressing for packing a cutaneous abscess
    Other Name: Iodoform
  • Device: Type of dressing - Aquacel
    Aquacel dressing
    Other Name: Aquacel
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2010)
92
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2009)
240
Actual Study Completion Date  ICMJE February 23, 2010
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00984022
Other Study ID Numbers  ICMJE 2008-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maricopa Integrated Health System
Study Sponsor  ICMJE Maricopa Integrated Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Madhumita Sinha, MD District Medical Group
PRS Account Maricopa Integrated Health System
Verification Date September 2017

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