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

This study has been completed.

Sponsor:

Information provided by:

Maricopa Integrated Health System

ClinicalTrials.gov Identifier:

NCT00984022

First received: September 22, 2009

Last updated: October 27, 2010

Last verified: October 2010

History of Changes

Results First Received: August 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Abscess Cellulitis
Interventions:	Device: Type of dressing - Iodoform Device: Type of dressing - Aquacel

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Iodoform Dressing	Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
Aquacel Dressing	Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.

Participant Flow: Overall Study

	Iodoform Dressing	Aquacel Dressing
STARTED	43	49
COMPLETED	33	35
NOT COMPLETED	10	14
Lost to Follow-up	10	14

Baseline Characteristics

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Reporting Groups

	Description
Iodoform Dressing	Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
Aquacel Dressing	Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
Total	Total of all reporting groups

Baseline Measures

	Iodoform Dressing	Aquacel Dressing	Total
Number of Participants [units: participants]	43	49	92
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	43	49	92
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	36.8 ± 12.6	39.2 ± 11.6	38.0 ± 12.0
Gender [units: participants]
Female	15	16	31
Male	28	33	61
Region of Enrollment [units: participants]
United States	43	49	92

Outcome Measures

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1. Primary:

Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess [ Time Frame: 2 weeks ]

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2. Secondary:

Change in Patient Rating of Pain [ Time Frame: Baseline and 2 weeks ]

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3. Secondary:

Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis. [ Time Frame: 2 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: David Drachman
Organization: Maricopa Integrated Health System
phone: 602-344-5161
e-mail: david.drachman@mihs.org

No publications provided

Responsible Party:	Madhumita Sinha, MD, District Medical Group
ClinicalTrials.gov Identifier:	NCT00984022 History of Changes
Other Study ID Numbers:	2008-003
Study First Received:	September 22, 2009
Results First Received:	August 11, 2010
Last Updated:	October 27, 2010
Health Authority:	United States: Institutional Review Board

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