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NCT Number: NCT00984022

Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following 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.

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Key information

Conditions

Abscess Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type of dressing - Iodoform

Device

Dressing for packing a cutaneous abscess

Other names: Iodoform

Type of dressing - Aquacel

Device

Aquacel dressing

Other names: Aquacel

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Valleywise Health

Other

Registry information

Official study title

Aquacel vs. Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage: A Randomized Control Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Sep 24, 2009
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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