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

Cellulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984022
• Other study ID #: 2008-003
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2009
• Last updated: September 5, 2017
• Start date: March 2008
• Est. completion date: February 23, 2010

Study information

• Verified date: September 2017
• Source: Maricopa Integrated Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 23, 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Cellulitis

Intervention

Device:
• Type of dressing - Iodoform
Dressing for packing a cutaneous abscess
• Type of dressing - Aquacel
Aquacel dressing

Locations

Country	Name	City	State
United States	Maricopa Integrated Health System	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Maricopa Integrated Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess	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	Change in Patient Rating of Pain	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
Secondary	Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.	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