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

Primary Purpose

Abscess, Cellulitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Type of dressing - Iodoform
Type of dressing - Aquacel
Sponsored by
Valleywise Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring abscess, MRSA, Aquacel dressing, Iodoform dressing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maricopa Integrated Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Iodoform dressing

Aquacel dressing

Arm Description

Iodoform dressing for cutaneous abscess

Aquacel dressing for cutaneous abscess

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Patient Rating of Pain
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.
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.

Full Information

First Posted
September 22, 2009
Last Updated
September 5, 2017
Sponsor
Valleywise Health
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1. Study Identification

Unique Protocol Identification Number
NCT00984022
Brief Title
Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage
Official Title
Aquacel vs. Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage: A Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
February 23, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valleywise Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess, Cellulitis
Keywords
abscess, MRSA, Aquacel dressing, Iodoform dressing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Aquacel vs. Iodoform Gauze
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iodoform dressing
Arm Type
Active Comparator
Arm Description
Iodoform dressing for cutaneous abscess
Arm Title
Aquacel dressing
Arm Type
Active Comparator
Arm Description
Aquacel dressing for cutaneous abscess
Intervention Type
Device
Intervention Name(s)
Type of dressing - Iodoform
Other Intervention Name(s)
Iodoform
Intervention Description
Dressing for packing a cutaneous abscess
Intervention Type
Device
Intervention Name(s)
Type of dressing - Aquacel
Other Intervention Name(s)
Aquacel
Intervention Description
Aquacel dressing
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in Patient Rating of Pain
Description
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.
Time Frame
Baseline and 2 weeks
Title
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhumita Sinha, MD
Organizational Affiliation
District Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maricopa Integrated Health System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States

12. IPD Sharing Statement

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

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