AbscessNCT00900510
Antibiotic Therapy After Incision and Drainage for Abscess
A study testing Incision and drainage and Trimethoprim/Sulfamethoxazole (Bactrim) in people with Abscess, run by Wake Forest University at 1 site in United States.
Trial summary
Background: Skin abscesses are a growing problem in the general pediatric population around the world. While the standard treatment for an abscess/boil is incision and drainage, many physicians also prescribe antibiotics, despite the lack of evidence that antibiotics are necessary to help the wound heal. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Abscess
- What is being tested?
- Incision and drainage and Trimethoprim/Sulfamethoxazole (Bactrim)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2011
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any child (age 6 months-18 years old) that:
- does not meet criteria for hospitalization and
- has only one localized abscess (>/= 2 cm of erythema and induration), which is clinically judged to be amenable to incision and drainage. (i.e., on clinical exam their is fluctuance, erythema, induration, and/or purulent drainage)
- has an abscess that is ± 7 days from onset, who requires surgical incision and drainage for a skin and soft-tissue abscess
Who cannot join
- children < 6 months of age
- children who require inpatient hospitalization - children with a medical condition in which adjuvant antibiotic therapy would be accepted standard of practice (i.e., history of neutropenia, cardiac surgery, indwelling prosthesis)
- children with a previously diagnosed immunodeficiency (HIV, Chronic Granulomatous Disease, Job's syndrome, chronic steroid use)
- children hospitalized within 2 months of presentation (due to higher rate of nosocomial MRSA colonization)
- abcesses located on the head or neck
- children with history of a sulfa allergy
Show all 11Show fewer
- abscesses caused by animal bite wounds
- children with Diabetes Mellitus
- abscesses arising from tattooing
- abscesses arising from vaccination sites
- pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: The Use of Adjuvant Antibiotic Therapy After Incision and Drainage for Pediatric Abscess: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial
Background: Skin abscesses are a growing problem in the general pediatric population around the world. While the standard treatment for an abscess/boil is incision and drainage, many physicians also prescribe antibiotics, despite the lack of evidence that antibiotics are necessary to help the wound heal. The purpose of this research study is to determine whether antibiotics are necessary after incision and drainage of a skin abscess in children. This is an important question because medical evidence has shown that using antibiotics when they are not needed has contributed to the increase of bacterial antibiotic resistance. In fact, several of the antibiotics that successfully killed Staph bacteria several years ago are now no longer effective because of antibiotic resistance. Now resistant forms of Staph bacteria, called "Community-Acquired Methicillin-Resistant Staph Aureus" (CA-MRSA), account for 50-85% of all pediatric skin abscesses. If antibiotics are not necessary then withholding them when appropriate may help slow the progression of antibiotic-resistant Staph infections.
Objective(s) and Hypothesis(es): The investigators believe that antibiotics are no better than placebo at achieving a cure after drainage of an abscess in a child. The objective of this study is to answer the question: Do antibiotics after abscess drainage result in a better chance of cure than placebo?
Potential Impact: If abscess drainage alone is shown to be as effective as drainage followed by antibiotics, then the routine use of antibiotics for this problem could be avoided. This would help limit the increasing antibiotic resistance of bacteria (especially CA-MRSA) in communities around the world. A well-designed study may provide the evidence to change the way children are treated for abscesses in a future where antibiotic resistant bacteria will be even more of a public health challenge.
- Conditions
- Abscess
- Being tested
- Incision and drainage, Trimethoprim/Sulfamethoxazole (Bactrim), Placebo
- Keywords
- subcutaneous abscess, Incision and drainage, Methicillin-resistant staphylococcus aureus
- 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.
Incision and drainageProcedure or surgery
Trimethoprim/Sulfamethoxazole (Bactrim)Drug
Trimethoprim/Sulfamethoxazole, oral
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Drainage and placebo | Experimental | Incision and drainage with placebo. Receives: Procedure: Incision and drainage; Drug: Placebo |
| Drainage with TMP/SX | Active comparator | Drainage with Bactrim Receives: Drug: Trimethoprim/Sulfamethoxazole (Bactrim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of abscess
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Why it stopped: Recruitment of this population in the hospital setting not practical.
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.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Pranikoff, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900510
- Sponsor's protocol ID
- IRB00008450
- Status last verified
- Dec 2014
- First submitted
- 11 May 2009
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Adjuvant Antibiotic Therapy After Incision and Drainage for Pediatric Abscess: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00900510
- Acronym / sponsor ID
- IRB00008450
- Conditions
- Abscess
- Keywords
- subcutaneous abscess, Incision and drainage, Methicillin-resistant staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment of this population in the hospital setting not practical.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 12 May 2009 (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.
Background: Skin abscesses are a growing problem in the general pediatric population around the world. While the standard treatment for an abscess/boil is incision and drainage, many physicians also prescribe antibiotics, despite the lack of evidence that antibiotics are necessary to help the wound heal. The purpose of this research study is to determine whether antibiotics are necessary after incision and drainage of a skin abscess in children. This is an important question because medical evidence has shown that using antibiotics when they are not needed has contributed to the increase of bacterial antibiotic resistance. In fact, several of the antibiotics that successfully killed Staph bacteria several years ago are now no longer effective because of antibiotic resistance. Now resistant forms of Staph bacteria, called "Community-Acquired Methicillin-Resistant Staph Aureus" (CA-MRSA), account for 50-85% of all pediatric skin abscesses. If antibiotics are not necessary then withholding them when appropriate may help slow the progression of antibiotic-resistant Staph infections.
Objective(s) and Hypothesis(es): The investigators believe that antibiotics are no better than placebo at achieving a cure after drainage of an abscess in a child. The objective of this study is to answer the question: Do antibiotics after abscess drainage result in a better chance of cure than placebo?
Potential Impact: If abscess drainage alone is shown to be as effective as drainage followed by antibiotics, then the routine use of antibiotics for this problem could be avoided. This would help limit the increasing antibiotic resistance of bacteria (especially CA-MRSA) in communities around the world. A well-designed study may provide the evidence to change the way children are treated for abscesses in a future where antibiotic resistant bacteria will be even more of a public health challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drainage and placebo | Experimental | Procedure: Incision and drainage, Drug: PlaceboIncision and drainage with placebo. |
| Drainage with TMP/SX | Active comparator | Drug: Trimethoprim/Sulfamethoxazole (Bactrim)Drainage with Bactrim |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Any child (age 6 months-18 years old) that:
Key exclusion criteria (11 listed)
- children < 6 months of age
- children who require inpatient hospitalization - children with a medical condition in which adjuvant antibiotic therapy would be accepted standard of practice (i.e., history of neutropenia, cardiac surgery, indwelling prosthesis)
- children with a previously diagnosed immunodeficiency (HIV, Chronic Granulomatous Disease, Job's syndrome, chronic steroid use)
- children hospitalized within 2 months of presentation (due to higher rate of nosocomial MRSA colonization)
- abcesses located on the head or neck
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 drainage | Procedure or surgery | Drainage and placebo |
| Trimethoprim/Sulfamethoxazole (Bactrim)Trimethoprim/Sulfamethoxazole, oral | Drug | Drainage with TMP/SX |
| Placebo | Drug | Drainage and placebo |
Primary outcome
Resolution of abscess
Time frame: 5-7 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 6 Nov 2017.
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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.
Thomas Pranikoff, M.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incision and drainage and Trimethoprim/Sulfamethoxazole (Bactrim) in people with Abscess, run by Wake Forest University 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 4 inclusion and 11 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 6 Nov 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.
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?
Resolution of abscess (time frame: 5-7 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 6 Nov 2017.