Superficial Abscess PackingNCT01281930
Abscess Packing Versus Wick Placement After Incision and Drainage
A study testing Full packing into abscess cavity and Wick placement into abscess cavity in people with Superficial Abscess Packing, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Abscesses or "boils" are becoming more common every year and are a common reason children come to the Emergency Department. For the abscess to heal the skin needs to be opened to let the pus come out. Often doctors put something called "packing material" or gauze into the abscess space to help aid in healing. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Superficial Abscess Packing
- What is being tested?
- Full packing into abscess cavity and Wick placement into abscess cavity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2015
- 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
- Well appearing patient
- Abscesses restricted to the superficial areas of the extremities, buttocks, abdominal and thoracic walls, and back
- Patients presenting Saturday-Wednesday
Who cannot join
- Fever >38 degrees celsius
- Ill appearing patient
- Underlying immunodeficiency or disorder leading to chronic abscess formation
- Any reason for admission to hospital beyond the need for sedation at the time of follow-up
- Thursday-Friday
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Abscesses or "boils" are becoming more common every year and are a common reason children come to the Emergency Department. For the abscess to heal the skin needs to be opened to let the pus come out. Often doctors put something called "packing material" or gauze into the abscess space to help aid in healing. It is not known if the type of "packing" that is done is necessary or if a more simple treatment is as good or better. With informed consent we randomly place a child into one (1) of two (2) groups in this study that will say if the child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece) of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment in the emergency department the child will be scheduled to follow-up in the Pediatric Acute Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this visit the healing of the wound will be checked by the staff in the clinic and will be scored. With this evaluation of the wound the hypothesis that for a simple superficial (skin) abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of traditional gauze packing.
- Conditions
- Superficial Abscess Packing
- Being tested
- Full packing into abscess cavity, Wick placement into abscess cavity
- Keywords
- Superficial abscess, packing material, wick, incision and drainage
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full packing into abscess cavityProcedure or surgery
After incision and drainage plain 1/4-1/2 inch gauze packing material is placed into the cavity to fill it
Wick placement into abscess cavityProcedure or surgery
After incision and drainage of the abscess a piece of plain gauze 1/4-1 inch packing material that is as wide as can be easily passed through the opening is placed into the cavity spanning one diameter of the cavity
| Study group | Role | What they receive |
|---|---|---|
| Wick placement into abscess cavity | Experimental | Not described Receives: Procedure: Wick placement into abscess cavity |
| Full packing of abscess cavity | Active comparator | Not described Receives: Procedure: Full packing into abscess cavity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abscess healing based upon clinical criteria and clinical judgement
Abscesses are assessed for pus accumulation, erythema from the wound, if the patient has a fever and the overall clinical judgment of the evaluating health care professional at the time of follow-up.
Measured: 24-72 hours
Secondary outcomes (5)
Pain since abscess drainage
Measured: 24-72 hours
Parent/guardian comfort with removing the packing material or wick from the abscess cavity
Measured: 24-72 hours
Parent/guardian assessment of the abscess wound at 2 weeks
Measured: 2 weeks
Parent/guardian assessment of pus drainage at 2 weeks
Measured: 2 weeks
Need for further treatment of same abscess within 2 weeks
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 Jan 2011 (estimated)
- Study startJun 2009
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Abscess PackingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281930
- Sponsor's protocol ID
- 09-0719 -201103241
- Status last verified
- Jun 2018
- First submitted
- 20 Jan 2011
- Last updated
- 19 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abscess Packing Versus Wick Placement After Incision and Drainage
- ClinicalTrials.gov ID
- NCT01281930
- Acronym / sponsor ID
- 09-0719 -201103241
- Conditions
- Superficial Abscess Packing
- Keywords
- Superficial abscess, packing material, wick, incision and drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Jan 2011 (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.
Abscesses or "boils" are becoming more common every year and are a common reason children come to the Emergency Department. For the abscess to heal the skin needs to be opened to let the pus come out. Often doctors put something called "packing material" or gauze into the abscess space to help aid in healing. It is not known if the type of "packing" that is done is necessary or if a more simple treatment is as good or better. With informed consent we randomly place a child into one (1) of two (2) groups in this study that will say if the child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece) of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment in the emergency department the child will be scheduled to follow-up in the Pediatric Acute Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this visit the healing of the wound will be checked by the staff in the clinic and will be scored. With this evaluation of the wound the hypothesis that for a simple superficial (skin) abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of traditional gauze packing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wick placement into abscess cavity | Experimental | Procedure: Wick placement into abscess cavity |
| Full packing of abscess cavity | Active comparator | Procedure: Full packing into abscess cavity |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Well appearing patient
- Abscesses restricted to the superficial areas of the extremities, buttocks, abdominal and thoracic walls, and back
- Patients presenting Saturday-Wednesday
Key exclusion criteria (5 listed)
- Fever >38 degrees celsius
- Ill appearing patient
- Underlying immunodeficiency or disorder leading to chronic abscess formation
- Any reason for admission to hospital beyond the need for sedation at the time of follow-up
- Thursday-Friday
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 |
|---|---|---|
| Full packing into abscess cavityAfter incision and drainage plain 1/4-1/2 inch gauze packing material is placed into the cavity to fill it | Procedure or surgery | Full packing of abscess cavity |
| Wick placement into abscess cavityAfter incision and drainage of the abscess a piece of plain gauze 1/4-1 inch packing material that is as wide as can be easily passed through the opening is placed into the cavity spanning one diameter of the cavity | Procedure or surgery | Wick placement into abscess cavity |
Primary outcome
Abscess healing based upon clinical criteria and clinical judgement
Time frame: 24-72 hours
Abscesses are assessed for pus accumulation, erythema from the wound, if the patient has a fever and the overall clinical judgment of the evaluating health care professional at the time of follow-up.
5 secondary outcomes
Pain since abscess drainage
Time frame: 24-72 hours
Parent/guardian comfort with removing the packing material or wick from the abscess cavity
Time frame: 24-72 hours
Parent/guardian assessment of the abscess wound at 2 weeks
Time frame: 2 weeks
Parent/guardian assessment of pus drainage at 2 weeks
Time frame: 2 weeks
Need for further treatment of same abscess within 2 weeks
Time frame: 2 weeks
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 19 Jun 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full packing into abscess cavity and Wick placement into abscess cavity in people with Superficial Abscess Packing, run by Washington University School of Medicine 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 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 19 Jun 2018. 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 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?
Abscess healing based upon clinical criteria and clinical judgement (time frame: 24-72 hours). 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 19 Jun 2018.