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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Connective Tissue Diseases
Infection
Inflammation
Pathologic Processes
Skin Diseases, Infectious
Suppuration

ClinicalTrials.gov processed this record on November 25, 2014