Packing Versus no Packing for Cutaneous Abscess

• ClinicalTrials.gov Identifier: NCT02822768
• Recruitment Status: Recruiting
• First Posted: July 4, 2016
• Last Update Posted: March 16, 2020
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: June 30, 2016
• First Posted Date: July 4, 2016
• Last Update Posted Date: March 16, 2020
• Study Start Date: August 2016
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 9, 2018)

Percentage of patients needing further treatment [ Time Frame: 14 days ]

follow-up call to determine if patient required further treatment beyond routine care

• Original Primary Outcome Measures (submitted: July 1, 2016): Percentage of patients needing further treatment [ Time Frame: 14 days ]

Current Secondary Outcome Measures (submitted: October 9, 2018)

Visual Analog Scale for Pain (VAS pain) post procedure [ Time Frame: 14 days ]

Measure pain score after procedure

• Original Secondary Outcome Measures (submitted: July 1, 2016): Visual Analog Scale for Pain (VAS pain) post procedure [ Time Frame: 14 days ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Packing Versus no Packing for Cutaneous Abscess
• Official Title: Is Routine Packing of Cutaneous Abscesses Necessary?
• Brief Summary: The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if routine packing of the abscess cavity affects the need for further interventions such as repeat incision and drainage, antibiotic administration or hospital admission.

Detailed Description

Study protocol:

1. Identification of a patient with a cutaneous abscess requiring incision and drainage
2. Written consent obtained from the patient

3. Study materials will be obtained

   • Enrolling physician fills out pre-procedure information (see data sheet)

   • Enrollment data sheet has instructions indicating whether patient is to receive packing or not

     • Use of random number generator to randomize all packets
   • Provider does abscess incision and drainage with or without packing according to the instructions
   • Enrolling physician fills out post-procedure information (see data sheet)
   • Patient returns within 48 hours for wound check with removal of packing if performed

   • Research coordinator or study physician calls the patient within 14 and 30 days after the procedure for follow-up

     • Information from a return visit and/or the telephone follow-up

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Cutaneous Abscess

Intervention

• Procedure: Packing
  The patient will receive packing as part of their wound care
• Other: No packing
  The patient will not receive packing as part of their wound care

Study Arms

• Active Comparator: Packing
  The patient is to have a long piece of gauze within the abscess cavity in an attempt to keep it open and allow purulent material to continue to drain after the initial incision and release of purulent material has been performed.
  Intervention: Procedure: Packing
• Placebo Comparator: No packing
  The patient is not to have packing of the abscess as part of the incision and drainage procedure
  Intervention: Other: No packing

Publications *

• 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.
• Abraham N, Doudle M, Carson P. Open versus closed surgical treatment of abscesses: a controlled clinical trial. Aust N Z J Surg. 1997 Apr;67(4):173-6.
• Stewart MP, Laing MR, Krukowski ZH. Treatment of acute abscesses by incision, curettage and primary suture without antibiotics: a controlled clinical trial. Br J Surg. 1985 Jan;72(1):66-7.
• Barnes SM, Milsom PL. Abscesses: an open and shut case! Arch Emerg Med. 1988 Dec;5(4):200-5. Review.
• Simms MH, Curran F, Johnson RA, Oates J, Givel JC, Chabloz R, ALexander-Williams J. Treatment of acute abscesses in the casualty department. Br Med J (Clin Res Ed). 1982 Jun 19;284(6332):1827-9.
• Sørensen C, Hjortrup A, Moesgaard F, Lykkegaard-Nielsen M. Linear incision and curettage vs. deroofing and drainage in subcutaneous abscess. A randomized clinical trial. Acta Chir Scand. 1987 Nov-Dec;153(11-12):659-60.
• Tonkin DM, Murphy E, Brooke-Smith M, Hollington P, Rieger N, Hockley S, Richardson N, Wattchow DA. Perianal abscess: a pilot study comparing packing with nonpacking of the abscess cavity. Dis Colon Rectum. 2004 Sep;47(9):1510-4. Epub 2004 Jul 8.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 1, 2016): 196
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2022
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. All patients 18 years of age and above
2. Patients that require a cutaneous abscess incision and drainage
3. English-speaking subjects only

Exclusion Criteria:

1. Unable to return for 48-hour follow-up.
2. Patients being admitted to the hospital or going to the operating room for incision and drainage
3. Pregnant patients
4. Patients less than 18 years of age
5. Prisoners or persons in police custody
6. Patients with infected bursa
7. Non-English speaking subjects

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Michael Darracq, MD, MPH; 559-499-6440; mdarracq@fresno.ucsf.edu

Contact: Jannet Castaneda, BA; 559-499-6435; jcastaneda@fresno.ucsf.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02822768
• Other Study ID Numbers: 2016052
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael Darracq, MD, MPH; UCSF - Fresno

• PRS Account: University of California, San Francisco
• Verification Date: March 2020