Trial Outcomes & Findings for Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage (NCT NCT00984022)

NCT ID: NCT00984022

Last Updated: 2017-10-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 92 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2017-10-04

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	43	49
Overall Study COMPLETED	33	35
Overall Study NOT COMPLETED	10	14

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	10	14

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Iodoform Dressing n=43 Participants 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 n=49 Participants Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	49 Participants n=7 Participants	92 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.8 years STANDARD_DEVIATION 12.6 • n=5 Participants	39.2 years STANDARD_DEVIATION 11.6 • n=7 Participants	38.0 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	33 Participants n=7 Participants	61 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	49 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Iodoform Dressing n=43 Participants 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 n=49 Participants Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess	6 Participants	19 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iodoform Dressing n=43 Participants 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 n=49 Participants Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
Change in Patient Rating of Pain	-1.23 Scores on a scale Standard Deviation 1.89	-1.82 Scores on a scale Standard Deviation 1.73

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iodoform Dressing n=43 Participants 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 n=49 Participants Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.	13 Participants	13 Participants

Adverse Events

Iodoform Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aquacel Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Drachman

Maricopa Integrated Health System

Phone: 602-344-5161

Email: david.drachman@mihs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place