Loop Drainage Versus Incision and Drainage for Abscesses

NCT03911518 | Withdrawn

• 1 other identifier: 19021803
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter randomized controlled trial of loop drainage versus traditional incision and drainage in adult patients presenting to the emergency department.

Conditions

Abscess of Skin and/or Subcutaneous Tissue

Keywords

incision and drainage; loop drainage; soft tissue infection; abscess

Outcome Measures

Primary Outcomes (1)

• Rate of Clinical Cure

  Defined as healing of the abscess without the need for further clinical intervention (change in antibiotics, repeat drainage, or admission)

  Days 10-14

Secondary Outcomes (6)

• Intra-Procedure Pain Rating

  Day 0

• Time to Complete Drainage

  Day 0

• Patient Satisfaction: Numeric rating scale

  Days 0, 10-14

• Provider Satisfaction: Numeric rating scale

  Day 0

• Recurrence Rate

  Day 30

Study Arms (2)

Control

ACTIVE COMPARATOR

Incision and drainage.

Procedure: Incision and drainage

Intervention

EXPERIMENTAL

Loop drainage.

Procedure: Loop drainage

Interventions

Loop drainage PROCEDURE

Loop drainage will occur via 2 small incisions, approximately 2 cm, with the cuff from the base of a sterile glove pulled through and then tied off.

Intervention

Incision and drainage PROCEDURE

The wound will be incised with a #11 blade scalpel along the point of maximal fluctuance, approximately 2-3 cm, and then all loculations bluntly dissected with a set of Kelly clamps. After drainage of pus, the wound will be loosely packed with gauze.

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 years or older
• Abscess is considered simple, purulent, and cutaneous
• Abscess is deemed amenable to outpatient drainage

You may not qualify if:

• Inability to speak English
• Abscess location of breast or face
• Pilonidal abscesses
• Concurrent use of chemotherapy or steroids
• Allergy to sulfa/trimethoprim or lidocaine
• Inability to provide consent
• Incarcerated patients
• Inability to give a valid contact number or email address
• Presence of multiple abscesses
• Abscess size less than 2 cm
• Pregnant patients
• History of glucose-6-phosphate dehydrogenase deficiency
• History of Steven Johnson's Syndrome
• Patients with fever greater than 100.4 Fahrenheit

Sponsors & Collaborators

• Gary Peksa: lead
• Brooke Army Medical Center: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• Loyola University: collaborator
• Kaiser Permanente: collaborator
• Stony Brook University: collaborator

Related Publications (7)

• 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.

  PMID: 25435407 BACKGROUND

• 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.

  PMID: 24928539 BACKGROUND

• Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014 Jul 15;59(2):e10-52. doi: 10.1093/cid/ciu444.

  PMID: 24973422 BACKGROUND

• 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.

  PMID: 21376200 BACKGROUND

• Gaszynski R, Punch G, Verschuer K. Loop and drain technique for subcutaneous abscess: a safe minimally invasive procedure in an adult population. ANZ J Surg. 2018 Jan;88(1-2):87-90. doi: 10.1111/ans.13709. Epub 2016 Sep 12.

  PMID: 27621209 BACKGROUND

• 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.

  PMID: 28162873 BACKGROUND

• 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.

  PMID: 28917436 BACKGROUND

MeSH Terms

Conditions

Surgical Wound; Soft Tissue Infections; Abscess

Interventions

Drainage

Condition Hierarchy (Ancestors)

Wounds and Injuries; Infections; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Gillian Schmitz, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An investigator blinded to treatment assignment determine the cosmetic healing rate at 90 days
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-investigator; Assistant Professor, Emergency Medicine

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: July 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share