AbscessPhase 3NCT01085929
Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses
A Phase 3 study testing Incision and Drainage and Ultrasound Guided Aspiration in people with Abscess and Cellulitis, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial summary
The incidence of skin and soft tissue infections has increased dramatically over the last decade, in part due to increased prevalence of community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abscess, Cellulitis
- What is being tested?
- Incision and Drainage and Ultrasound Guided Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presenting to emergency department with skin abscess
- abscess required surgical drainage
- healthy appearing
Who cannot join
- pregnant
- unable to give consent
- abscess located in oral cavity
- abscess located on genitalia
- abscess located intra-gluteal at coccyx
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Ultrasound Guided Needle Drainage Versus Formal Incision and Drainage of Superficial Soft Tissue Abscesses in the Emergency Department Setting
The incidence of skin and soft tissue infections has increased dramatically over the last decade, in part due to increased prevalence of community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). Incision and drainage (I\&D) is considered the primary intervention, however some clinicians prefer ultrasound guided needle aspiration (US Asp). The investigators performed a randomized trial comparing US Asp to I\&D for uncomplicated skin and soft tissue abscesses, with a subgroup analysis of patients with CA-MRSA.
- Conditions
- Abscess, Cellulitis
- Being tested
- Incision and Drainage, Ultrasound Guided Aspiration
- Keywords
- abscess, infection, ultrasound guidance, incision and drainage, needle aspiration, skin, ultrasound
- Medical subject headings
- Abscess, Cellulitis, Infections, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incision and DrainageProcedure or surgery
Surgical incision of the skin surface followed by expression of purulence with or without debridement or manual exploration of abscess cavity.
Ultrasound Guided AspirationProcedure or surgery
Ultrasound is used to identify the abscess cavity. An 18 gauge needle is introduced into the abscess cavity and manual aspiration of the abscess contents is attempted.
| Study group | Role | What they receive |
|---|---|---|
| Incision and Drainage | Active comparator | Abscess underwent incision and drainage Receives: Procedure: Incision and Drainage |
| Ultrasound guided needle aspiration | Active comparator | Ultrasound was used to identify the abscess location. A needle was introduced into the abscess cavity and aspiration of the contents were attempted. Receives: Procedure: Ultrasound Guided Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful drainage of abscess
Clinical outcome at 7 days
Measured: 7 days
Secondary outcomes (2)
Successful drainage of abscess
Healing of abscess following drainage procedure at day 2
Measured: 2 days
Ability to evacuate purulence from abscess
Amount of purulence produced by drainage procedure on day 1
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbscessStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Investigators
- Romolo Gaspari, MD, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085929
- Sponsor's protocol ID
- UMass12522
- Status last verified
- Mar 2010
- First submitted
- 10 Mar 2010
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Needle Drainage Versus Formal Incision and Drainage of Superficial Soft Tissue Abscesses in the Emergency Department Setting
- ClinicalTrials.gov ID
- NCT01085929
- Acronym / sponsor ID
- UMass12522
- Conditions
- Abscess, Cellulitis
- Keywords
- abscess, infection, ultrasound guidance, incision and drainage, needle aspiration, skin, ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Aug 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of skin and soft tissue infections has increased dramatically over the last decade, in part due to increased prevalence of community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). Incision and drainage (I\&D) is considered the primary intervention, however some clinicians prefer ultrasound guided needle aspiration (US Asp). The investigators performed a randomized trial comparing US Asp to I\&D for uncomplicated skin and soft tissue abscesses, with a subgroup analysis of patients with CA-MRSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incision and Drainage | Active comparator | Procedure: Incision and DrainageAbscess underwent incision and drainage |
| Ultrasound guided needle aspiration | Active comparator | Procedure: Ultrasound Guided AspirationUltrasound was used to identify the abscess location. A needle was introduced into the abscess cavity and aspiration of the contents were attempted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presenting to emergency department with skin abscess
- abscess required surgical drainage
- healthy appearing
Key exclusion criteria (5 listed)
- pregnant
- unable to give consent
- abscess located in oral cavity
- abscess located on genitalia
- abscess located intra-gluteal at coccyx
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 |
|---|---|---|
| Incision and DrainageSurgical incision of the skin surface followed by expression of purulence with or without debridement or manual exploration of abscess cavity. | Procedure or surgery | Incision and Drainage |
| Ultrasound Guided AspirationUltrasound is used to identify the abscess cavity. An 18 gauge needle is introduced into the abscess cavity and manual aspiration of the abscess contents is attempted. | Procedure or surgery | Ultrasound guided needle aspiration |
Primary outcome
Successful drainage of abscess
Time frame: 7 days
Clinical outcome at 7 days
2 secondary outcomes
Successful drainage of abscess
Time frame: 2 days
Ability to evacuate purulence from abscess
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2010.
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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.
Romolo Gaspari, MD, PhD principal investigator
University of Massachusetts, Worcester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Incision and Drainage and Ultrasound Guided Aspiration in people with Abscess and Cellulitis, run by University of Massachusetts, Worcester at 2 sites 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 3 inclusion and 5 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 12 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful drainage of abscess (time frame: 7 days). 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 12 Mar 2010.