Comparison of Loop Drainage Versus Incision and Drainage for Abscesses in Children

NCT02443272 | Completed

• 1 other identifier: CR-14-114
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare abscess drainage utilizing the vessel loop technique in children to the standard incision and drainage technique with the endpoint to determine if rates of treatment failure are non-inferior.

Conditions

Abscess of Skin and/or Subcutaneous Tissue

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  Requiring reinstrumentation of abscess, or hospital admission for IV antibiotics

  14 days

Secondary Outcomes (8)

• Parental satisfaction with procedure

  1 Day

• Physician satisfaction with procedure

  1 Day

• Level of anxiety with wound care at home

  14 Days

• Level of simplicity with wound care at home

  14 Days

• Cosmetic success

  14 Days

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Receive standard incision and drainage

Procedure: Incision and Drainage

Intervention Arm

EXPERIMENTAL

Receive minimal invasive loop drainage using the Vesi-loop device

Procedure: Vessel Loop Drainage

Interventions

Vessel Loop Drainage PROCEDURE

Minimally invasive approach will utilize a vesi-loop device for the vessel loop drainage technique by placing 2 peripheral stab incisions into the abscess with a tunnel through the abscess cavity, and loop passed through the tunnel and tied atop the skin.

Intervention Arm

Incision and Drainage PROCEDURE

Standard of care treatment will utilize incision and drainage over the center of the abscess cavity with or without packing at physicians discretion.

Control Arm

Eligibility Criteria

• Age: 29 Days - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Physical findings suggestive of skin abscess warranting incision and drainage (determined by treating physician)

You may not qualify if:

• Abscess not suitable for drainage in the ED (eg. \<1 cm induration, \>15 cm induration)
• Immunocompromised status (eg. diabetic patient or taking immunosuppressive medication)
• Need for hospitalization following drainage
• Abscess located above the clavicles or significantly involving genitals/pilonidal region
• Previous instrumentation to the abscess
• Primary language not English or Spanish
• High probability of loss to follow up (parent does not commit to both mandatory follow up appointments)

Sponsors & Collaborators

• Seton Healthcare Family: lead
• Scientific, Education and Research Foundation of UTSW Austin: collaborator

Study Sites (1)

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Related Publications (15)

• Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.

  PMID: 3880635 BACKGROUND

• Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann Emerg Med. 2010 May;55(5):401-7. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5.

  PMID: 19409657 BACKGROUND

• Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26.

  PMID: 20346539 BACKGROUND

• 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.

  PMID: 24074675 BACKGROUND

• Kessler DO, Krantz A, Mojica M. Randomized trial comparing wound packing to no wound packing following incision and drainage of superficial skin abscesses in the pediatric emergency department. Pediatr Emerg Care. 2012 Jun;28(6):514-7. doi: 10.1097/PEC.0b013e3182587b20.

  PMID: 22653459 BACKGROUND

• O'Malley GF, Dominici P, Giraldo P, Aguilera E, Verma M, Lares C, Burger P, Williams E. Routine packing of simple cutaneous abscesses is painful and probably unnecessary. Acad Emerg Med. 2009 May;16(5):470-3. doi: 10.1111/j.1553-2712.2009.00409.x. Epub 2009 Apr 10.

  PMID: 19388915 BACKGROUND

• 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.

  PMID: 20223328 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

• 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.

  PMID: 20638546 BACKGROUND

• Alder AC, Thornton J, McHard K, Buckins L, Barber R, Skinner MA. A comparison of traditional incision and drainage versus catheter drainage of soft tissue abscesses in children. J Pediatr Surg. 2011 Oct;46(10):1942-7. doi: 10.1016/j.jpedsurg.2011.05.025.

  PMID: 22008332 BACKGROUND

• Wright TN, Gilligan L, Zhurbich O, Davenport DL, Draus JM Jr. Minimally invasive drainage of subcutaneous abscesses reduces hospital cost and length of stay. South Med J. 2013 Dec;106(12):689-92. doi: 10.1097/SMJ.0000000000000032.

  PMID: 24305529 BACKGROUND

• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

  PMID: 11427329 BACKGROUND

• Tsze DS, von Baeyer CL, Bulloch B, Dayan PS. Validation of self-report pain scales in children. Pediatrics. 2013 Oct;132(4):e971-9. doi: 10.1542/peds.2013-1509. Epub 2013 Sep 2.

  PMID: 23999954 BACKGROUND

• Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.

  PMID: 18090752 BACKGROUND

• Rencher L, Whitaker W, Schechter-Perkins E, Wilkinson M. Comparison of Minimally Invasive Loop Drainage and Standard Incision and Drainage of Cutaneous Abscesses in Children Presenting to a Pediatric Emergency Department: A Prospective, Randomized, Noninferiority Trial. Pediatr Emerg Care. 2021 Oct 1;37(10):e615-e620. doi: 10.1097/PEC.0000000000001732.

  PMID: 30839438 DERIVED

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Logan R Rencher, DO

  UT-Austin Dell Children's Medical Center PEM Fellowship

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 13, 2015
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

US (1)