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

Phase 2

Completed

• Conditions: Abscess; Cellulitis
• Interventions: Device: Type of dressing - Aquacel; Device: Type of dressing - Iodoform

• Registration Number: NCT00984022
• Lead Sponsor: Valleywise Health

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Study Completion: 2010-02-23
• Results First Submitted: 2010-08-11
• Results First Submitted QC: 2010-10-26
• Results First Posted: 2010-10-27
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aquacel dressing	Type of dressing - Aquacel	Aquacel dressing for cutaneous abscess
Iodoform dressing	Type of dressing - Iodoform	Iodoform dressing for cutaneous abscess

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess	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 Outcome Measures

Name	Time	Method
Change in Patient Rating of Pain	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.
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.	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.

Trial Locations

Locations (1)

Maricopa Integrated Health System; 🇺🇸 Phoenix, Arizona, United States