Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population
Primary Purpose
Abscess, Drain Abscess
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
incision and loop drainage
traditional incision and drainage (I&D)
Sponsored by
About this trial
This is an interventional treatment trial for Abscess focused on measuring Emergency Medicine, Abscess, Incision and Drainage, Incision and Loop Drainage, Sterile Glove
Eligibility Criteria
**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
- Active Duty and DoD beneficiaries aged 18 to 65 years old.
- Abscess that requires drainage.
Exclusion Criteria:
- Abscess of the hand, foot, or face, immunocompromised by disease or medications.
- Temperature greater than 100.4 degrees Fahrenheit.
- Systolic blood pressure less than 90 mmHG.
- Abscess is too small to treat with incision and drainage (as seen on ultrasound).
- Patient is too ill to be included in the study determined by clinical judgement of the treating provider.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
traditional incision and drainage (I&D)
incision and loop drainage
Arm Description
incision and loop drainage utilizing the rolled ring of a sterile glove technique
Outcomes
Primary Outcome Measures
Number of subjects with Treatment effectiveness
A record review will be performed to identify patients that had to return to the Emergency Department up to 30 days after the procedure due to complications. Attempts will be made to contact patients who fail to follow up. If unable to contact, a record review will be conducted in attempt to ascertain abscess status. If these measures are unsuccessful, patient treatment will be considered a success.
Record Review: Treatment failure will be defined as need for repeat drainage, intravenous antibiotic, hospitalization or surgical treatment within 7 days.
Subject pain: Visual Analogue Scale
Data will be collected using the VAS. Patients mark will be measured in millimeters and recorded.
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Lower scores mean a better outcome and higher scores mean greater pain severity.
Provider satisfaction: Visual Analogue Scale
Data will be collected using the VAS. Provider mark will be measured in millimeters and recorded.
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.
Subject satisfaction: Visual Analogue Scale
Data will be collected using the VAS. Subject mark will be measured in millimeters and recorded.
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04241471
Brief Title
Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population
Official Title
Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study published rendering this protocol/study obsolete.
Study Start Date
May 4, 2020 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
bryan malcolm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
When using the rolled ring of a sterile glove as a loop drain in incision and loop drainage, is it superior to incision and drainage for treatment of a cutaneous abscess in 18 to 65 year-old patients presenting to the Emergency Department, Family Health Clinic, Family Medicine Residency Clinic, or Internal Medicine Clinic?
Hypothesis: When treating a cutaneous abscess, incision and loop drainage utilizing the rolled ring of a sterile glove as a loop drain is superior to the standard (incision and drainage) yielding a treatment failure rate of 1% at seven to ten days.
Detailed Description
Practicing medicine in an austere environment is fraught with challenges. One primary challenge is that clinicians will frequently be practicing without the supplies needed for specific indicated purpose. For treatment of a cutaneous abscess, sterile gloves are readily available whether at home or when deployed. It can be much more difficult to come across a penrose or vessel loop. In addition, follow up for wound repacking and reassessment is a struggle. Patients may have to move from location to location or have work hours that make it difficult to return to the clinic. The loop technique utilizing the rolled ring of a sterile glove solves both of these problems. Sterile gloves are always available and the Loop technique requires little to no follow up. Additional benefits include: subjects may experience less pain, improved cosmesis, faster healing, and decreased complication rates with incision and loop drainage utilizing the rolled ring of a sterile glove compared to traditional incision and drainage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess, Drain Abscess
Keywords
Emergency Medicine, Abscess, Incision and Drainage, Incision and Loop Drainage, Sterile Glove
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
traditional incision and drainage (I&D)
Arm Type
Active Comparator
Arm Title
incision and loop drainage
Arm Type
Experimental
Arm Description
incision and loop drainage utilizing the rolled ring of a sterile glove technique
Intervention Type
Procedure
Intervention Name(s)
incision and loop drainage
Intervention Description
incision and loop drainage utilizing the rolled ring of a sterile glove technique
Intervention Type
Device
Intervention Name(s)
traditional incision and drainage (I&D)
Intervention Description
traditional incision and drainage (I&D)
Primary Outcome Measure Information:
Title
Number of subjects with Treatment effectiveness
Description
A record review will be performed to identify patients that had to return to the Emergency Department up to 30 days after the procedure due to complications. Attempts will be made to contact patients who fail to follow up. If unable to contact, a record review will be conducted in attempt to ascertain abscess status. If these measures are unsuccessful, patient treatment will be considered a success.
Record Review: Treatment failure will be defined as need for repeat drainage, intravenous antibiotic, hospitalization or surgical treatment within 7 days.
Time Frame
30 days post-procedure
Title
Subject pain: Visual Analogue Scale
Description
Data will be collected using the VAS. Patients mark will be measured in millimeters and recorded.
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Lower scores mean a better outcome and higher scores mean greater pain severity.
Time Frame
Pre-procedure, mid-procedure, post-procedure
Title
Provider satisfaction: Visual Analogue Scale
Description
Data will be collected using the VAS. Provider mark will be measured in millimeters and recorded.
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.
Time Frame
post-procedure
Title
Subject satisfaction: Visual Analogue Scale
Description
Data will be collected using the VAS. Subject mark will be measured in millimeters and recorded.
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.
Time Frame
7-10 day follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
Active Duty and DoD beneficiaries aged 18 to 65 years old.
Abscess that requires drainage.
Exclusion Criteria:
Abscess of the hand, foot, or face, immunocompromised by disease or medications.
Temperature greater than 100.4 degrees Fahrenheit.
Systolic blood pressure less than 90 mmHG.
Abscess is too small to treat with incision and drainage (as seen on ultrasound).
Patient is too ill to be included in the study determined by clinical judgement of the treating provider.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul F Crawford, MD
Organizational Affiliation
United States Air Force
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan on sharing data.
Citations:
PubMed Identifier
28069270
Citation
Aprahamian CJ, Nashad HH, DiSomma NM, Elger BM, Esparaz JR, McMorrow TJ, Shadid AM, Kao AM, Holterman MJ, Kanard RC, Pearl RH. Treatment of subcutaneous abscesses in children with incision and loop drainage: A simplified method of care. J Pediatr Surg. 2017 Sep;52(9):1438-1441. doi: 10.1016/j.jpedsurg.2016.12.018. Epub 2016 Dec 30.
Results Reference
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PubMed Identifier
30661820
Citation
Brody AM, Gallien J, Murphy D, Marogil J. A Novel Silicon Device for the Packing of Cutaneous Abscesses. J Emerg Med. 2019 Mar;56(3):298-300. doi: 10.1016/j.jemermed.2018.12.009. Epub 2019 Jan 17.
Results Reference
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PubMed Identifier
28917436
Citation
Gottlieb M, Peksa GD. Comparison of the loop technique with incision and drainage for soft tissue abscesses: A systematic review and meta-analysis. Am J Emerg Med. 2018 Jan;36(1):128-133. doi: 10.1016/j.ajem.2017.09.007. Epub 2017 Sep 10.
Results Reference
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PubMed Identifier
25435407
Citation
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.
Results Reference
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PubMed Identifier
24074675
Citation
Leinwand M, Downing M, Slater D, Beck M, Burton K, Moyer D. Incision and drainage of subcutaneous abscesses without the use of packing. J Pediatr Surg. 2013 Sep;48(9):1962-5. doi: 10.1016/j.jpedsurg.2013.01.027.
Results Reference
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PubMed Identifier
29530657
Citation
Long B, April MD. Is Loop Drainage Technique More Effective for Treatment of Soft Tissue Abscess Compared With Conventional Incision and Drainage? Ann Emerg Med. 2019 Jan;73(1):19-21. doi: 10.1016/j.annemergmed.2018.02.006. Epub 2018 Mar 9. No abstract available.
Results Reference
background
PubMed Identifier
21376200
Citation
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.
Results Reference
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PubMed Identifier
28162873
Citation
Ozturan IU, Dogan NO, Karakayali O, Ozbek AE, Yilmaz S, Pekdemir M, Suner S. Comparison of loop and primary incision & drainage techniques in adult patients with cutaneous abscess: A preliminary, randomized clinical trial. Am J Emerg Med. 2017 Jun;35(6):830-834. doi: 10.1016/j.ajem.2017.01.036. Epub 2017 Jan 22.
Results Reference
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PubMed Identifier
32406569
Citation
Schechter-Perkins EM, Dwyer KH, Amin A, Tyler MD, Liu J, Nelson KP, Mitchell PM. Loop Drainage Is Noninferior to Traditional Incision and Drainage of Cutaneous Abscesses in the Emergency Department. Acad Emerg Med. 2020 Nov;27(11):1150-1157. doi: 10.1111/acem.13981. Epub 2020 May 14.
Results Reference
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Citation
Thompson 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.
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Citation
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Links:
URL
https://baylor.primo.exlibrisgroup.com/discovery/fulldisplay?docid=wos000445699100183&context=PC&vid=01BUL_INST:BAYLOR&lang=en&search_scope=MyInst_and_CI&adaptor=Primo%20Central&tab=Everything&query=any,contains,incision%20and%20loop%20drainage&offset=0.
Description
loop drainage
Learn more about this trial
Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population
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