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
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 22, 2009
CompletedFirst Posted
Study publicly available on registry
September 24, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2010
CompletedResults Posted
Study results publicly available
October 27, 2010
CompletedOctober 4, 2017
September 1, 2017
1.5 years
September 22, 2009
August 11, 2010
September 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess
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.
2 weeks
Secondary Outcomes (2)
Change in Patient Rating of Pain
Baseline and 2 weeks
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.
2 weeks
Study Arms (2)
Iodoform dressing
ACTIVE COMPARATORIodoform dressing for cutaneous abscess
Aquacel dressing
ACTIVE COMPARATORAquacel dressing for cutaneous abscess
Interventions
Dressing for packing a cutaneous abscess
Eligibility Criteria
You may qualify if:
- presenting to Maricopa Medical Center ED with cutaneous abscess requiring incision and drainage
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maricopa Integrated Health System
Phoenix, Arizona, 85008, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Drachman
- Organization
- Maricopa Integrated Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Madhumita Sinha, MD
District Medical Group
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2009
First Posted
September 24, 2009
Study Start
March 1, 2008
Primary Completion
September 1, 2009
Study Completion
February 23, 2010
Last Updated
October 4, 2017
Results First Posted
October 27, 2010
Record last verified: 2017-09