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

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ClinicalTrials.gov Identifier: NCT00984022
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : October 27, 2010
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Maricopa Integrated Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Abscess
Cellulitis
Interventions Device: Type of dressing - Iodoform
Device: Type of dressing - Aquacel
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Iodoform Dressing Aquacel Dressing
Hide Arm/Group Description 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 for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
Period Title: Overall Study
Started 43 49
Completed 33 35
Not Completed 10 14
Reason Not Completed
Lost to Follow-up             10             14
Arm/Group Title Iodoform Dressing Aquacel Dressing Total
Hide Arm/Group Description 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 for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage. Total of all reporting groups
Overall Number of Baseline Participants 43 49 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 49 participants 92 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
 100.0%
49
 100.0%
92
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 49 participants 92 participants
36.8  (12.6) 39.2  (11.6) 38.0  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 49 participants 92 participants
Female
15
  34.9%
16
  32.7%
31
  33.7%
Male
28
  65.1%
33
  67.3%
61
  66.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 49 participants 92 participants
43 49 92
1.Primary Outcome
Title Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iodoform Dressing Aquacel Dressing
Hide Arm/Group Description:
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 for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
Overall Number of Participants Analyzed 43 49
Measure Type: Number
Unit of Measure: Participants
6 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iodoform Dressing, Aquacel Dressing
Comments The percentages achieving 30% or greater reduction in the surface area of the abscess were compared with Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0003
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Change in Patient Rating of Pain
Hide Description 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.
Time Frame Baseline and 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iodoform Dressing Aquacel Dressing
Hide Arm/Group Description:
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 for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
Overall Number of Participants Analyzed 43 49
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.23  (1.89) -1.82  (1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iodoform Dressing, Aquacel Dressing
Comments Repeated measures ANOVA using 2 X 2 factorial design, with one between-subjects factor (Group) and one within-subjects factor (Time). Null hypothesis is: The type of dressing does not affect patient pain ratings.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .043
Comments Main effect for type of dressing.
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iodoform Dressing Aquacel Dressing
Hide Arm/Group Description:
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 for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
Overall Number of Participants Analyzed 43 49
Measure Type: Number
Unit of Measure: Participants
13 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iodoform Dressing, Aquacel Dressing
Comments Fisher's exact test was used to compare the percentage of individuals achieving a 30% or greater reduction in cellulitis surface area between the Iodoform and Aquacel groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .847
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iodoform Dressing Aquacel Dressing
Hide Arm/Group Description 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 for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
All-Cause Mortality
Iodoform Dressing Aquacel Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Iodoform Dressing Aquacel Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/49 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Iodoform Dressing Aquacel Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/49 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Drachman
Organization: Maricopa Integrated Health System
Phone: 602-344-5161
EMail: david.drachman@mihs.org
Layout table for additonal information
Responsible Party: Maricopa Integrated Health System
ClinicalTrials.gov Identifier: NCT00984022     History of Changes
Other Study ID Numbers: 2008-003
First Submitted: September 22, 2009
First Posted: September 24, 2009
Results First Submitted: August 11, 2010
Results First Posted: October 27, 2010
Last Update Posted: October 4, 2017