We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00984022
First Posted: September 24, 2009
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maricopa Integrated Health System
  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
Intervention Model: Parallel Assignment
Intervention Model Description:
Aquacel vs. Iodoform Gauze
Masking: None (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 ]
    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 ]
    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.


Enrollment: 92
Study Start Date: March 2008
Study Completion Date: February 23, 2010
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Maricopa Integrated Health System
ClinicalTrials.gov Identifier: NCT00984022     History of Changes
Other Study ID Numbers: 2008-003
First Submitted: September 22, 2009
First Posted: September 24, 2009
Results First Submitted: August 11, 2010
Results First Posted: October 27, 2010
Last Update Posted: October 4, 2017
Last Verified: September 2017

Keywords provided by Maricopa Integrated Health System:
abscess
MRSA
Aquacel dressing
Iodoform dressing

Additional relevant MeSH terms:
Abscess
Cellulitis
Suppuration
Infection
Inflammation
Pathologic Processes
Skin Diseases, Infectious
Connective Tissue Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents