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

September 5, 2017 updated by: Valleywise Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Integrated Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iodoform dressing
Iodoform dressing for cutaneous abscess
Device: Type of dressing - Iodoform
Dressing for packing a cutaneous abscess
Other Names:
  • Iodoform
Active Comparator: Aquacel dressing
Aquacel dressing for cutaneous abscess
Device: Type of dressing - Aquacel
Aquacel dressing
Other Names:
  • Aquacel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valleywise Health

Investigators

  • Principal Investigator: Madhumita Sinha, MD, District Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

February 23, 2010

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abscess

Clinical Trials on Type of dressing - Iodoform

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe