Cutaneous AbscessLoopDrainageNCT01897675
A Comparison of Techniques for Treating Skin Abscesses
A study testing Incision and Drainage with packing (wick) placement and Abscess drainage with loop placement in people with Cutaneous Abscess, run by Boston Medical Center at 1 site in United States.
Trial summary
Management of abscesses traditionally involves incision and drainage (I\&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cutaneous Abscess
- What is being tested?
- Incision and Drainage with packing (wick) placement and Abscess drainage with loop placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 9 Mar 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient over 18 years of age
- Presenting to the Boston Medical Center main Emergency Department or Urgent Care area for initial treatment of a skin abscess
- English speaking
- Able to provide written informed consent
- Willing to return in 14 days for follow-up visit
- Able to give a telephone number for follow-up contact
Who cannot join
- Previously treated for this abscess
- Altered mental status
- Patients with active psychiatric issues that preclude their ability to provide informed consent
- Previously enrolled in the study
- Abscess is not amenable to treatment by an Emergency Physician in the Emergency Department
- Abscess is post-operative or post-procedure
Show all 9Show fewer
- Clinician determines abscess is not amenable to drainage by particular method
- Abscess is too small for packing or loop
- Need for hospital admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?
Management of abscesses traditionally involves incision and drainage (I\&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation.
Recently there have been attempts to employ less invasive techniques for abscess management. One novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature.
Read more
We propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management.
Patients presenting to the main or urgent care areas of the Emergency Department at Boston Medical Center for treatment of an abscess will be considered for enrollment as potential subjects. After the treating clinician identifies the patient as an appropriate subject, a Research Associate (RA) will approach the patient and obtain written informed consent to enroll in the study. The subject will then be randomized to the management arm of either loop drainage or traditional I\&D. The clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. Fourteen days after initial visit, subjects will return for follow-up. The subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications.
The study investigators will then compare outcomes between the two study groups.
- Conditions
- Cutaneous Abscess
- Being tested
- Incision and Drainage with packing (wick) placement, Abscess drainage with loop placement
- Keywords
- Cutaneous Abscess, Emergency Department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incision and Drainage with packing (wick) placementProcedure or surgery
Abscess drainage with loop placementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Incision and Drainage with Packing | Active comparator | Abscess is cared for in the standard fashion, using an incision and drainage with packing (wick) placement. Packing to be changed every 2-3 days, at the discretion of the treating clinician, until abscess is considered resolved Receives: Procedure: Incision and Drainage with packing (wick) placement |
| Loop Drainage | Experimental | Abscess is cared for using a minimally invasive abscess drainage with loop placement technique. Two (or more) stab incisions are made in the abscess, the cavity is probed and pus is drained, and a vessel loop is inserted and tied off. The patient manipulates the loop 3 times per day, and removes the loop when all redness is gone and no more pus is present Receives: Procedure: Abscess drainage with loop placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abscess Resolution
If no, which sign is present (check all that apply):
- Fluctuance
- Drainage
- Induration
- Warmth
- Tenderness
- Other __________
Measured: 14 days
Secondary outcomes (5)
Patient Satisfaction Immediately After Procedure
How Satisfied is Patient Immediately after Procedure (likert scale) Did Patient Feel Discomfort During Procedure (likert scale)
Measured: Time 0
Cosmetic Outcome
Appearance according to wound scale
Wound Scale (presence or absence of)
- Step-off of borders
- Contour irregularities
- Wound margin separation
- Edge inversion
- Excessive distortion
- Overall appearance
Measured: 14 days
Patient Satisfaction after Abscess Resolution
Patient Satisfaction with:
Number of Follow Up Visits (likert scale) Cosmetic Appearance (likert scale) Pain (likert scale) Overall abscess care (likert scale
Measured: 14 Days
Number of Follow Up Visits
Number of follow-up visits made to either Emergency Department or outpatient clinic for abscess care
Measured: 14 days
Number of Complications
need for new incision in the same abscess, extension of the original incision, starting antibiotics, changing antibiotics, admission
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2017
- Study completion9 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cutaneous 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elissa Schechter-Perkins, Boston Medical Center
- Investigators
- Elissa Schechter-Perkins, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897675
- Sponsor's protocol ID
- H-32294
- Acronym
- LoopDrainage
- Status last verified
- Apr 2018
- First submitted
- 9 Jul 2013
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McNamara WF, Hartin CW Jr, Escobar MA, Yamout SZ, Lau ST, Lee YH. An alternative to open incision and drainage for community-acquired soft tissue abscesses in children. J Pediatr Surg. 2011 Mar;46(3):502-6. doi: 10.1016/j.jpedsurg.2010.08.019.
PubMed 21376200Ladd AP, Levy MS, Quilty J. Minimally invasive technique in treatment of complex, subcutaneous abscesses in children. J Pediatr Surg. 2010 Jul;45(7):1562-6. doi: 10.1016/j.jpedsurg.2010.03.025.
PubMed 20638546
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Loop Drainage of a Cutaneous Abscess in the Emergency Department as Effective as Incision and Drainage With Packing?
- ClinicalTrials.gov ID
- NCT01897675
- Acronym / sponsor ID
- LoopDrainage / H-32294
- Conditions
- Cutaneous Abscess
- Keywords
- Cutaneous Abscess, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 12 Jul 2013 (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.
Management of abscesses traditionally involves incision and drainage (I\&D). Abscesses are frequently are "packed" or stented open with the presence of a wick, and traditional care requires re-visits every 2-3 days to have the packing removed and replaced, until finally the abscess cavity has closed, usually 1-2 weeks after initial presentation.
Recently there have been attempts to employ less invasive techniques for abscess management. One novel technique, "loop drainage", has been reported in case reports/case series for management of a variety of types of abscesses in the surgical subspecialty literature.
We propose to conduct a randomized prospective study comparing the efficacy of the loop drainage technique with the traditional incision and drainage technique of abscess management.
Patients presenting to the main or urgent care areas of the Emergency Department at Boston Medical Center for treatment of an abscess will be considered for enrollment as potential subjects. After the treating clinician identifies the patient as an appropriate subject, a Research Associate (RA) will approach the patient and obtain written informed consent to enroll in the study. The subject will then be randomized to the management arm of either loop drainage or traditional I\&D. The clinician will fill out a data sheet describing the abscess characteristics, and then perform either loop drainage or incision and drainage, depending on randomization and the subject will fill out a satisfaction survey. Fourteen days after initial visit, subjects will return for follow-up. The subject will fill out a satisfaction survey, and a study investigator blinded to the treatment group will assess the subject for abscess resolution, cosmetic outcome, number of follow-up visits, and complications.
The study investigators will then compare outcomes between the two study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incision and Drainage with Packing | Active comparator | Procedure: Incision and Drainage with packing (wick) placementAbscess is cared for in the standard fashion, using an incision and drainage with packing (wick) placement. Packing to be changed every 2-3 days, at the discretion of the treating clinician, until abscess is considered resolved |
| Loop Drainage | Experimental | Procedure: Abscess drainage with loop placementAbscess is cared for using a minimally invasive abscess drainage with loop placement technique. Two (or more) stab incisions are made in the abscess, the cavity is probed and pus is drained, and a vessel loop is inserted and tied off. The patient manipulates the loop 3 times per day, and removes the loop when all redness is gone and no more pus is present |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient over 18 years of age
- Presenting to the Boston Medical Center main Emergency Department or Urgent Care area for initial treatment of a skin abscess
- English speaking
- Able to provide written informed consent
- Willing to return in 14 days for follow-up visit
Key exclusion criteria (9 listed)
- Previously treated for this abscess
- Altered mental status
- Patients with active psychiatric issues that preclude their ability to provide informed consent
- Previously enrolled in the study
- Abscess is not amenable to treatment by an Emergency Physician in the Emergency Department
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 with packing (wick) placement | Procedure or surgery | Incision and Drainage with Packing |
| Abscess drainage with loop placement | Procedure or surgery | Loop Drainage |
Primary outcome
Abscess Resolution
Time frame: 14 days
If no, which sign is present (check all that apply): 1. Fluctuance 2. Drainage 3. Induration 4. Warmth 5. Tenderness 6. Other __________
5 secondary outcomes
Patient Satisfaction Immediately After Procedure
Time frame: Time 0
Cosmetic Outcome
Time frame: 14 days
Patient Satisfaction after Abscess Resolution
Time frame: 14 Days
Number of Follow Up Visits
Time frame: 14 days
Number of Complications
Time frame: 14 days
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 6 Apr 2018.
- Background: PubMed 21376200McNamara WF, Hartin CW Jr, Escobar MA, Yamout SZ, Lau ST, Lee YH. An alternative to open incision and drainage for community-acquired soft tissue abscesses in children. J Pediatr Surg. 2011 Mar;46(3):502-6. doi: 10.1016/j.jpedsurg.2010.08.019.
- Background: PubMed 20638546Ladd AP, Levy MS, Quilty J. Minimally invasive technique in treatment of complex, subcutaneous abscesses in children. J Pediatr Surg. 2010 Jul;45(7):1562-6. doi: 10.1016/j.jpedsurg.2010.03.025.
- Video of Loop Drainage Technique for Abscess careLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Elissa Schechter-Perkins, MD, MPH principal investigator
Boston Medical Center
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 with packing (wick) placement and Abscess drainage with loop placement in people with Cutaneous Abscess, run by Boston Medical Center 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 6 inclusion and 9 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 6 Apr 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 Resolution (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01897675, which also lists 2 linked publications.
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 Apr 2018.