Abscess of Skin and/or Subcutaneous TissueNCT02697279
Loop Drainage: Effectiveness in Treating Cutaneous Abscesses
A study testing Traditional Incision and Drainage. and Loop drainage in people with Abscess of Skin and/or Subcutaneous Tissue, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous abscesses. Traditional incision and drainage (I\&D), with or without packing of cutaneous abscesses has long been the accepted standard of care. This procedure is often very painful for the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abscess of Skin and/or Subcutaneous Tissue
- What is being tested?
- Traditional Incision and Drainage. and Loop drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 1 Feb 2018
- 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 or older
- Presents to ED with simple cutaneous abscess
- Provides informed consent.
Who cannot join
- Under 18 years of age
- Abscess too small for performance of procedure
- Signs of systemic infection
- Need for hospitalization
- Previously treated for current abscess
- Clinician determines abscess would not be amenable to drainage by loop technique
Show all 10Show fewer
- Patients known to be pregnant
- Incarcerated patients
- Students / Employees of the facility
- Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Systems
Baltimore, Maryland, 21201
About this study
Official title: Evaluation of Loop Drainage Technique Versus Standard Incision and Drainage for Treatment of Simple Soft Tissue Abscesses
In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous abscesses. Traditional incision and drainage (I\&D), with or without packing of cutaneous abscesses has long been the accepted standard of care. This procedure is often very painful for the patient. Additionally, compliance with wound care and follow-up can present barriers to proper care and healing. Research has suggested that incision and loop drainage of an abscess may be another effective treatment for simple cutaneous abscess. Thus far, research into this procedure has been limited to the pediatric population with small sample sizes. In these previous studies, this technique was found to be an effective and less painful treatment for abscesses. Research has not been done in the adult population using this procedure. If this procedure is found to be as effective and less painful in the adult population, then it should be considered as a potential preferred I\&D method for cutaneous abscess in the ED.
Read the detailed description
Patients who meet study criteria for treatment of a simple cutaneous abscess and desire to be a part of this study, will be consented. Study subjects will be enrolled and randomly assigned to either the study or control groups.
Control Group- standard I \& D method for cutaneous abscess.
Study Group- Loop Technique:
- Gather all of your material and bring to bedside
- Clean area with chlorhexidine or iodine swabs
- Anesthetize area
- Use your scalpel to make small 5mm incision at most fluctuant area of abscess
- Explore cavity with your hemostat and break down loculations
- Make second incision less than 4cm away from first incision. Feel borders of abscess, and try to make second incision as far within cavity as you can.
- For larger abscesses can repeat step 5 thus creating several LOOPs.
- Irrigate cavity with saline flush
- Pass hemostat through both incisions and pull loop vessel, penrose, or bottom of glove through. Keep your loop device equal in length on both sides.
- Tie loop device loosely over 30cc syringe to form LOOP. Usually 5-6 knots. This helps prevent loop from falling out prematurely.
- Slide syringe out, and trim free ends of loop. Make sure loop is mobile.
- Cover site with dry dressing. Follow-Up-
- Wound check in 1-2 days
- Patient may manage drain at home by rotating it to facilitate drainage and prevent adhesion
- Patient will be instructed to return to the Emergency Department for drain removal in 5-7 days.
- Being tested
- Traditional Incision and Drainage., Loop drainage
- Keywords
- Abscess, Loop, Drainage
- Medical subject headings
- Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Incision and Drainage.Procedure or surgery
Control Group- Standard treatment of a simple cutaneous abscess with traditional I\&D technique with or without packing utilizing a standard I\&D kit.
Loop drainageProcedure or surgery
Study Group- Treatment of a simple cutaneous abscess with the loop drainage technique utilizing an standard I\&D kit and the cuff of a sterile glove for a loop device.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Incision and Drainage | Active comparator | Treatment of a simple cutaneous abscess with traditional incision and drainage with or without packing, decision made at the discretion of the provider. Receives: Procedure: Traditional Incision and Drainage. |
| Loop drainage | Experimental | Treatment of a simple cutaneous abscess with incision and drainage using the loop drainage technique. Receives: Procedure: Loop drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure failure rate
Determining the difference in failure rates between the study group and control group. Treatment failure is a composite outcome defined as having the presence of any of the following: requiring a 2nd incision and drainage procedure, a patient that requires administration of antibiotics after the initial treatment period due to worsening clinical status, a patient that requires hospitalization after the initial treatment period due to worsening clinical status.
Measured: 5 -7 days after procedure
Secondary outcomes (2)
Difference in pain associated with the procedure using a visual analog pain scale
To evaluate the difference in pain between the experimental and control groups associated with the procedure using a visual analog pain scale (0-100).
Measured: Measured after the procedure on day 1
Patient Satisfaction using a visual analog pain scale
To measure the difference in patient satisfaction with overall treatment between the study and control groups using the visual analog scale (0-100).
Measured: 5-7 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startOct 2016
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Why it stopped: Unable to enroll the appropriate number of subjects within a reasonable timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Abscess of Skin and/or Subcutaneous TissueStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Gentry Wilkerson, University of Maryland, Baltimore
- Investigators
- R. Gentry Wilkerson, MD, Principal investigator, U of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697279
- Sponsor's protocol ID
- HP-00066974
- Status last verified
- Dec 2021
- First submitted
- 4 Feb 2016
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ladd 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 20638546Kushnir VA, Mosquera C. Novel technique for management of Bartholin gland cysts and abscesses. J Emerg Med. 2009 May;36(4):388-90. doi: 10.1016/j.jemermed.2008.05.019. Epub 2008 Nov 26.
PubMed 19038518Ladde 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 25435407Thompson DO. Loop drainage of cutaneous abscesses using a modified sterile glove: a promising technique. J Emerg Med. 2014 Aug;47(2):188-91. doi: 10.1016/j.jemermed.2014.04.035. Epub 2014 Jun 11.
PubMed 24928539McNamara 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 21376200Tsoraides SS, Pearl RH, Stanfill AB, Wallace LJ, Vegunta RK. Incision and loop drainage: a minimally invasive technique for subcutaneous abscess management in children. J Pediatr Surg. 2010 Mar;45(3):606-9. doi: 10.1016/j.jpedsurg.2009.06.013.
PubMed 20223328Taira BR, Singer AJ, Thode HC Jr, Lee CC. National epidemiology of cutaneous abscesses: 1996 to 2005. Am J Emerg Med. 2009 Mar;27(3):289-92. doi: 10.1016/j.ajem.2008.02.027.
PubMed 19328372
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Loop Drainage Technique Versus Standard Incision and Drainage for Treatment of Simple Soft Tissue Abscesses
- ClinicalTrials.gov ID
- NCT02697279
- Acronym / sponsor ID
- HP-00066974
- Keywords
- Abscess, Loop, Drainage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll the appropriate number of subjects within a reasonable timeframe.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 3 Mar 2016 (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.
In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous abscesses. Traditional incision and drainage (I\&D), with or without packing of cutaneous abscesses has long been the accepted standard of care. This procedure is often very painful for the patient. Additionally, compliance with wound care and follow-up can present barriers to proper care and healing. Research has suggested that incision and loop drainage of an abscess may be another effective treatment for simple cutaneous abscess. Thus far, research into this procedure has been limited to the pediatric population with small sample sizes. In these previous studies, this technique was found to be an effective and less painful treatment for abscesses. Research has not been done in the adult population using this procedure. If this procedure is found to be as effective and less painful in the adult population, then it should be considered as a potential preferred I\&D method for cutaneous abscess in the ED.
Detailed description
Patients who meet study criteria for treatment of a simple cutaneous abscess and desire to be a part of this study, will be consented. Study subjects will be enrolled and randomly assigned to either the study or control groups.
Control Group- standard I \& D method for cutaneous abscess.
Study Group- Loop Technique:
- Gather all of your material and bring to bedside
- Clean area with chlorhexidine or iodine swabs
- Anesthetize area
- Use your scalpel to make small 5mm incision at most fluctuant area of abscess
- Explore cavity with your hemostat and break down loculations
- Make second incision less than 4cm away from first incision. Feel borders of abscess, and try to make second incision as far within cavity as you can.
- For larger abscesses can repeat step 5 thus creating several LOOPs.
- Irrigate cavity with saline flush
- Pass hemostat through both incisions and pull loop vessel, penrose, or bottom of glove through. Keep your loop device equal in length on both sides.
- Tie loop device loosely over 30cc syringe to form LOOP. Usually 5-6 knots. This helps prevent loop from falling out prematurely.
- Slide syringe out, and trim free ends of loop. Make sure loop is mobile.
- Cover site with dry dressing. Follow-Up-
- Wound check in 1-2 days
- Patient may manage drain at home by rotating it to facilitate drainage and prevent adhesion
- Patient will be instructed to return to the Emergency Department for drain removal in 5-7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Incision and Drainage | Active comparator | Procedure: Traditional Incision and Drainage.Treatment of a simple cutaneous abscess with traditional incision and drainage with or without packing, decision made at the discretion of the provider. |
| Loop drainage | Experimental | Procedure: Loop drainageTreatment of a simple cutaneous abscess with incision and drainage using the loop drainage technique. |
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 or older
- Presents to ED with simple cutaneous abscess
- Provides informed consent.
Key exclusion criteria (10 listed)
- Under 18 years of age
- Abscess too small for performance of procedure
- Signs of systemic infection
- Need for hospitalization
- Previously treated for current abscess
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 |
|---|---|---|
| Traditional Incision and Drainage.Control Group- Standard treatment of a simple cutaneous abscess with traditional I\&D technique with or without packing utilizing a standard I\&D kit. | Procedure or surgery | Traditional Incision and Drainage |
| Loop drainageStudy Group- Treatment of a simple cutaneous abscess with the loop drainage technique utilizing an standard I\&D kit and the cuff of a sterile glove for a loop device. | Procedure or surgery | Loop drainage |
Primary outcome
Procedure failure rate
Time frame: 5 -7 days after procedure
Determining the difference in failure rates between the study group and control group. Treatment failure is a composite outcome defined as having the presence of any of the following: requiring a 2nd incision and drainage procedure, a patient that requires administration of antibiotics after the initial treatment period due to worsening clinical status, a patient that requires hospitalization after the initial treatment period due to worsening clinical status.
2 secondary outcomes
Difference in pain associated with the procedure using a visual analog pain scale
Time frame: Measured after the procedure on day 1
Patient Satisfaction using a visual analog pain scale
Time frame: 5-7 days after procedure
Results and safety
The study was stopped early (reason given: Unable to enroll the appropriate number of subjects within a reasonable timeframe.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- 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.
- Background: PubMed 19038518Kushnir VA, Mosquera C. Novel technique for management of Bartholin gland cysts and abscesses. J Emerg Med. 2009 May;36(4):388-90. doi: 10.1016/j.jemermed.2008.05.019. Epub 2008 Nov 26.
- 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.
- Background: PubMed 24928539Thompson DO. Loop drainage of cutaneous abscesses using a modified sterile glove: a promising technique. J Emerg Med. 2014 Aug;47(2):188-91. doi: 10.1016/j.jemermed.2014.04.035. Epub 2014 Jun 11.
- 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 20223328Tsoraides SS, Pearl RH, Stanfill AB, Wallace LJ, Vegunta RK. Incision and loop drainage: a minimally invasive technique for subcutaneous abscess management in children. J Pediatr Surg. 2010 Mar;45(3):606-9. doi: 10.1016/j.jpedsurg.2009.06.013.
- Background: PubMed 19328372Taira BR, Singer AJ, Thode HC Jr, Lee CC. National epidemiology of cutaneous abscesses: 1996 to 2005. Am J Emerg Med. 2009 Mar;27(3):289-92. doi: 10.1016/j.ajem.2008.02.027.
- Individual participant dataSharing planned: No
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.
R. Gentry Wilkerson, MD principal investigator
U of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Incision and Drainage. and Loop drainage in people with Abscess of Skin and/or Subcutaneous Tissue, run by University of Maryland, Baltimore 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 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: stopped early, as of the sponsor's last update on 5 Jan 2022. 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 stopped early (reason given: Unable to enroll the appropriate number of subjects within a reasonable timeframe.). Results are not available in the source record.
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?
Procedure failure rate (time frame: 5 -7 days after procedure). 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 NCT02697279, which also lists 7 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 5 Jan 2022.