Clinical trial NCT04241471: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Abscess
Drain Abscess
Keywords: Emergency Medicine
Abscess
Incision and Drainage
Incision and Loop Drainage
Sterile Glove
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2020-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of subjects with Treatment effectiveness
timeFrame: 30 days post-procedure
measure: Subject pain: Visual Analogue Scale
timeFrame: Pre-procedure, mid-procedure, post-procedure
measure: Provider satisfaction: Visual Analogue Scale
timeFrame: post-procedure
measure: Subject satisfaction: Visual Analogue Scale
timeFrame: 7-10 day follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: United States Air Force
name: Paul F Crawford, MD
role: STUDY_DIRECTOR
References:
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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.
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.
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.
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: Gaspari RJ, Sanseverino A, Gleeson T. Abscess Incision and Drainage With or Without Ultrasonography: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jan;73(1):1-7. doi: 10.1016/j.annemergmed.2018.05.014. Epub 2018 Aug 17.