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

NCT ID: NCT00984022

Last Updated: 2017-10-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-02-23

Brief Summary

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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

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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.

Conditions

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Abscess Cellulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Aquacel vs. Iodoform Gauze
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iodoform dressing

Iodoform dressing for cutaneous abscess

Group Type ACTIVE_COMPARATOR

Type of dressing - Iodoform

Intervention Type DEVICE

Dressing for packing a cutaneous abscess

Aquacel dressing

Aquacel dressing for cutaneous abscess

Group Type ACTIVE_COMPARATOR

Type of dressing - Aquacel

Intervention Type DEVICE

Aquacel dressing

Interventions

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Type of dressing - Iodoform

Dressing for packing a cutaneous abscess

Intervention Type DEVICE

Type of dressing - Aquacel

Aquacel dressing

Intervention Type DEVICE

Other Intervention Names

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Iodoform Aquacel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valleywise Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madhumita Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

District Medical Group

Locations

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Maricopa Integrated Health System

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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2008-003

Identifier Type: -

Identifier Source: org_study_id