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
Results First Received: August 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Abscess
Cellulitis
Interventions: Device: Type of dressing - Iodoform
Device: Type of dressing - Aquacel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Iodoform Dressing Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
Aquacel Dressing Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.

Participant Flow:   Overall Study
    Iodoform Dressing     Aquacel Dressing  
STARTED     43     49  
COMPLETED     33     35  
NOT COMPLETED     10     14  
Lost to Follow-up                 10                 14  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Iodoform Dressing Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
Aquacel Dressing Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
Total Total of all reporting groups

Baseline Measures
    Iodoform Dressing     Aquacel Dressing     Total  
Number of Participants  
[units: participants]
  43     49     92  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     43     49     92  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  36.8  ± 12.6     39.2  ± 11.6     38.0  ± 12.0  
Gender  
[units: participants]
     
Female     15     16     31  
Male     28     33     61  
Region of Enrollment  
[units: participants]
     
United States     43     49     92  



  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess   [ Time Frame: 2 weeks ]

2.  Secondary:   Change in Patient Rating of Pain   [ Time Frame: Baseline and 2 weeks ]

3.  Secondary:   Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Drachman
Organization: Maricopa Integrated Health System
phone: 602-344-5161
e-mail: david.drachman@mihs.org


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