AbscessNCT03398746
The LOOP Trial in Treatment of Skin Abscesses
A study testing LOOP Technique and Standard incision and drainage in people with Abscess, run by Orlando Regional Medical Center.
Trial summary
This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP technique or 2) standard packing technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abscess
- What is being tested?
- LOOP Technique and Standard incision and drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2009to 5 Nov 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subcutaneous skin abscesses necessitating drainage
Who cannot join
- Abscess was on the hand, foot, or face
- Requiring admission or operative intervention
About this study
Official title: The LOOP Trial: A Study Comparing the Use of the LOOP Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses in a Level I Emergency Department
This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP technique or 2) standard packing technique.
Read the detailed description
This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Patients were excluded if the abscess was on the hand, foot, or face or if it required admission or operative intervention. Patients were followed over 10 days to determine the primary outcome of treatment failure defined by need for admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain after insertion and patient satisfaction using a 10-point numeric rating.
- Conditions
- Abscess
- Being tested
- LOOP Technique, Standard incision and drainage
- Keywords
- soft tissue infection, MRSA
- Medical subject headings
- Abscess, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOOP TechniqueProcedure or surgery
Placement of subcutaneous loop drain
Standard incision and drainageProcedure or surgery
Incise and drain with placement of packing
| Study group | Role | What they receive |
|---|---|---|
| LOOP Technique | Experimental | Placement of subcutaneous loop drain Receives: Procedure: LOOP Technique |
| Incision and Drainage | Active comparator | Standard Incision and Drainage Technique Receives: Procedure: Standard incision and drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure
Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature
Measured: 10 Days
Secondary outcomes (5)
Procedure Pain
Procedure Pain using Likert scale 1-10
Measured: At time of procedure
Ease of procedure
Ease of procedure using Likert 1-10 scale
Measured: At time of procedure
Ease of care
Ease of care using 1-10 Likert scale
Measured: During 10 days
Pain on follow-up
Pain on follow-up using 1-10 Likert scale
Measured: 10 days
Patient satisfaction
Patient satisfaction using Patient derived Likert scale
Measured: During 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start22 Jan 2009
- Primary completion5 Nov 2012
- Study completion5 Nov 2012
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 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
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Ladde, Orlando Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398746
- Sponsor's protocol ID
- 09.005.01
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ladde JG, Baker S, Rodgers CN, Papa L. The LOOP technique: a novel incision and drainage technique in the treatment of skin abscesses in a pediatric ED. Am J Emerg Med. 2015 Feb;33(2):271-6. doi: 10.1016/j.ajem.2014.10.014. Epub 2014 Oct 16.
PubMed 25435407Ladde J, Baker S, Lilburn N, Wan M, Papa L. A Randomized Controlled Trial of Novel Loop Drainage Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses. Acad Emerg Med. 2020 Dec;27(12):1229-1240. doi: 10.1111/acem.14106. Epub 2020 Oct 11.
PubMed 32770686
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LOOP Trial: A Study Comparing the Use of the LOOP Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses in a Level I Emergency Department
- ClinicalTrials.gov ID
- NCT03398746
- Acronym / sponsor ID
- 09.005.01
- Conditions
- Abscess
- Keywords
- soft tissue infection, MRSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Orlando Regional Medical CenterUniversity, hospital or other
- Study start
- 22 Jan 2009 (actual)
- Primary completion
- 5 Nov 2012 (actual)
- Study completion
- 5 Nov 2012 (actual)
- First posted
- 12 Jan 2018 (actual)
- 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.
This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP technique or 2) standard packing technique.
Detailed description
This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Patients were excluded if the abscess was on the hand, foot, or face or if it required admission or operative intervention. Patients were followed over 10 days to determine the primary outcome of treatment failure defined by need for admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain after insertion and patient satisfaction using a 10-point numeric rating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOOP Technique | Experimental | Procedure: LOOP TechniquePlacement of subcutaneous loop drain |
| Incision and Drainage | Active comparator | Procedure: Standard incision and drainageStandard Incision and Drainage Technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subcutaneous skin abscesses necessitating drainage
Key exclusion criteria (2 listed)
- Abscess was on the hand, foot, or face
- Requiring admission or operative intervention
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 |
|---|---|---|
| LOOP TechniquePlacement of subcutaneous loop drain | Procedure or surgery | LOOP Technique |
| Standard incision and drainageIncise and drain with placement of packing | Procedure or surgery | Incision and Drainage |
Primary outcome
Treatment Failure
Time frame: 10 Days
Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature
5 secondary outcomes
Procedure Pain
Time frame: At time of procedure
Ease of procedure
Time frame: At time of procedure
Ease of care
Time frame: During 10 days
Pain on follow-up
Time frame: 10 days
Patient satisfaction
Time frame: During 10 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 12 Jan 2018.
- Background: PubMed 25435407Ladde JG, Baker S, Rodgers CN, Papa L. The LOOP technique: a novel incision and drainage technique in the treatment of skin abscesses in a pediatric ED. Am J Emerg Med. 2015 Feb;33(2):271-6. doi: 10.1016/j.ajem.2014.10.014. Epub 2014 Oct 16.
- Derived from this study: PubMed 32770686Ladde J, Baker S, Lilburn N, Wan M, Papa L. A Randomized Controlled Trial of Novel Loop Drainage Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses. Acad Emerg Med. 2020 Dec;27(12):1229-1240. doi: 10.1111/acem.14106. Epub 2020 Oct 11.
- Link to PubMed ArticleLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LOOP Technique and Standard incision and drainage in people with Abscess, run by Orlando Regional Medical Center.
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 1 inclusion and 2 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Treatment Failure (time frame: 10 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 NCT03398746, 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 12 Jan 2018.