Uncomplicated Cutaneous AbscessNCT01698996
A Randomized Blinded Trial of Abscess Management With Packing vs No Packing
A study testing Packing vs No Packing in people with Uncomplicated Cutaneous Abscess, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Adult patients presenting to the emergency department with superficial cutaneous abscesses will be randomized after incision and drainage to standard care with wound packing or no packing to determine if there is a difference in the proportion of complications between the two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncomplicated Cutaneous Abscess
- What is being tested?
- Packing vs No Packing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Mar 2016
- Phase
- Interventional
- 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
- ≥ 18 years
- Abscess ≤ 5cm in diameter
- Truncal or extremity location
Who cannot join
- Post-operative abscess (abscess in location of operative incision, operation within the last 4 months)
- HIV/immunocompromised/transplant recipient/chronic oral steroid use
- Fever at triage (temp ≥38 degrees Celsius)
- Abscess secondary to Crohn's
- Multiple abscesses requiring drainage
- Prior participation in the study for the same abscess
Show all 10Show fewer
- Incision and drainage performed with no packing required, or where abscess cavity is <1 cm max diameter
- Bartholins/perigenital, perianal, or facial abscesses
- Complicated abscesses (fistula, suspicion of muscular extension, consultation/direct referral to general surgery)
- Inability to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Adult patients presenting to the emergency department with superficial cutaneous abscesses will be randomized after incision and drainage to standard care with wound packing or no packing to determine if there is a difference in the proportion of complications between the two groups.
- Conditions
- Uncomplicated Cutaneous Abscess
- Being tested
- Packing vs No Packing
- Keywords
- abscess, packing, emergency medicine, wound care, incision and drainage
- Medical subject headings
- Abscess, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packing vs No PackingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| No Packing | Active comparator | No Packing Receives: Procedure: Packing vs No Packing |
| Packing | Experimental | Packing Receives: Procedure: Packing vs No Packing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of complications (defined as a composite of the following: need for repeat incision and drainage by physician, need for admission to hospital, or need for escalation to intravenous antibiotics)
Measured: 7 days
Secondary outcomes (1)
Proportion of wounds "closed" at 1 week (wound size <0.5 cm length and depth and no drainage)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Cutaneous AbscessStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Shah, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Amit P Shah, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698996
- Sponsor's protocol ID
- 102928
- Status last verified
- Mar 2015
- First submitted
- 1 Oct 2012
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blinded Trial of Abscess Management With Packing vs No Packing
- ClinicalTrials.gov ID
- NCT01698996
- Acronym / sponsor ID
- 102928
- Conditions
- Uncomplicated Cutaneous Abscess
- Keywords
- abscess, packing, emergency medicine, wound care, incision and drainage
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (estimated)
- First posted
- 3 Oct 2012 (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.
Adult patients presenting to the emergency department with superficial cutaneous abscesses will be randomized after incision and drainage to standard care with wound packing or no packing to determine if there is a difference in the proportion of complications between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Packing | Active comparator | Procedure: Packing vs No PackingNo Packing |
| Packing | Experimental | Procedure: Packing vs No PackingPacking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years
- Abscess ≤ 5cm in diameter
- Truncal or extremity location
Key exclusion criteria (10 listed)
- Post-operative abscess (abscess in location of operative incision, operation within the last 4 months)
- HIV/immunocompromised/transplant recipient/chronic oral steroid use
- Fever at triage (temp ≥38 degrees Celsius)
- Abscess secondary to Crohn's
- Multiple abscesses requiring drainage
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 |
|---|---|---|
| Packing vs No Packing | Procedure or surgery | No Packing, Packing |
Primary outcome
Proportion of complications (defined as a composite of the following: need for repeat incision and drainage by physician, need for admission to hospital, or need for escalation to intravenous antibiotics)
Time frame: 7 days
1 secondary outcome
Proportion of wounds "closed" at 1 week (wound size <0.5 cm length and depth and no drainage)
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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.
Amit P Shah, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Packing vs No Packing in people with Uncomplicated Cutaneous Abscess, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 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: withdrawn, as of the sponsor's last update on 31 Mar 2015. 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 Canada. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of complications (defined as a composite of the following: need for repeat incision and drainage by physician, need for admission to hospital, or need for escalation to intravenous antibiotics) (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 31 Mar 2015.