AbscessPhase 2NCT00984022
Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage
A Phase 2 study testing Type of dressing - Iodoform and Type of dressing - Aquacel in people with Abscess and Cellulitis, run by Valleywise Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abscess, Cellulitis
- What is being tested?
- Type of dressing - Iodoform and Type of dressing - Aquacel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to 23 Feb 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presenting to Maricopa Medical Center ED with cutaneous abscess requiring incision and drainage
Who cannot join
- 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
Show all 10Show fewer
- facial abscess
- suspected osteomyelitis or septic arthritis
- diabetic foot, decubitis, or ischaemic ulcers
- unable to provide informed consent or assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Maricopa Integrated Health System
Phoenix, Arizona, 85008
About this study
Official title: Aquacel vs. Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage: A Randomized Control Study
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.
Read the 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.
- Conditions
- Abscess, Cellulitis
- Being tested
- Type of dressing - Iodoform, Type of dressing - Aquacel
- Keywords
- abscess, MRSA, Aquacel dressing, Iodoform dressing
- Medical subject headings
- Abscess, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of dressing - IodoformDevice
Also called Iodoform
Dressing for packing a cutaneous abscess
Type of dressing - AquacelDevice
Also called Aquacel
Aquacel dressing
| Study group | Role | What they receive |
|---|---|---|
| Iodoform dressing | Active comparator | Iodoform dressing for cutaneous abscess Receives: Device: Type of dressing - Iodoform |
| Aquacel dressing | Active comparator | Aquacel dressing for cutaneous abscess Receives: Device: Type of dressing - Aquacel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (2)
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.
Measured: Baseline and 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completion23 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aquacel vs. Iodoform Gauze
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valleywise Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madhumita Sinha, MD, Principal investigator, District Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984022
- Sponsor's protocol ID
- 2008-003
- Status last verified
- Sep 2017
- First submitted
- 22 Sep 2009
- Last updated
- 4 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquacel vs. Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT00984022
- Acronym / sponsor ID
- 2008-003
- Conditions
- Abscess, Cellulitis
- Keywords
- abscess, MRSA, Aquacel dressing, Iodoform dressing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Valleywise HealthUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- 23 Feb 2010 (actual)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Posted 27 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Aquacel vs. Iodoform Gauze
| Arm | Type | Receives |
|---|---|---|
| Iodoform dressing | Active comparator | Device: Type of dressing - IodoformIodoform dressing for cutaneous abscess |
| Aquacel dressing | Active comparator | Device: Type of dressing - AquacelAquacel dressing for cutaneous abscess |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- presenting to Maricopa Medical Center ED with cutaneous abscess requiring incision and drainage
Key exclusion criteria (10 listed)
- known sensitivity to Aquacel
- pregnant, nursing, or expecting to become pregnant
- incarcerated patient
- prior treatment of same abscess with incision and drainage
- multiple abscesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of dressing - IodoformAlso: IodoformDressing for packing a cutaneous abscess | Device | Iodoform dressing |
| Type of dressing - AquacelAlso: AquacelAquacel dressing | Device | Aquacel dressing |
Primary outcome
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess
Time frame: 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.
2 secondary outcomes
Change in Patient Rating of Pain
Time frame: Baseline and 2 weeks
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhumita Sinha, MD principal investigator
District Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Type of dressing - Iodoform and Type of dressing - Aquacel in people with Abscess and Cellulitis, run by Valleywise Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.