Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population

Abscess Clinical Trial

Official title:

Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population: A Randomized Control Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04241471
• Other study ID #: FWH20200046H
• Status: Withdrawn
• Phase: N/A
• Start date: May 4, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: February 2021
• Source: Mike O'Callaghan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

**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.

Related Conditions & MeSH terms

• Abscess
• Drain Abscess
• Surgical Wound

Intervention

Procedure:
• incision and loop drainage
incision and loop drainage utilizing the rolled ring of a sterile glove technique

Device:
• traditional incision and drainage (I&D)
traditional incision and drainage (I&D)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
bryan malcolm

References & Publications (12)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Özturan IU, Dogan NÖ, Karakayali O, Özbek 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. — View Citation

Schechter-Perkins, E.M., K.H. Dwyer, A. Amin, M.D. Tyler, J. Liu, K.P. Nelson, and P.M. Mitchell. "182 Loop Drainage Is Noninferior to Traditional Incision and Drainage of Cutaneous Abscesses in the Emergency Department." Annals of Emergency Medicine 70, no. 4 (October 2017): S73-74. https://doi.org/10.1016/j.annemergmed.2017.07.209.

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. — View Citation

Tsoraides 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days post-procedure
Primary	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.	Pre-procedure, mid-procedure, post-procedure
Primary	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.	post-procedure
Primary	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.	7-10 day follow-up

External Links

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