Clinical trial NCT02822768: Packing Versus no Packing for Cutaneous Abscess
Official title: Is Routine Packing of Cutaneous Abscesses Necessary?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cutaneous Abscess
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Percentage of patients needing further treatment
timeFrame: 14 days
Secondary outcomes:
measure: Visual Analog Scale for Pain (VAS pain) post procedure
timeFrame: 14 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
Study officials:
affiliation: UCSF - Fresno
name: Michael Darracq, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1111/j.1445-2197.1997.tb01934.x.
citation: 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. doi: 10.1002/bjs.1800720125.
citation: Barnes SM, Milsom PL. Abscesses: an open and shut case! Arch Emerg Med. 1988 Dec;5(4):200-5. doi: 10.1136/emj.5.4.200.
citation: 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. doi: 10.1136/bmj.284.6332.1827.
citation: Sorensen 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.
citation: 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. doi: 10.1007/s10350-004-0620-1. Epub 2004 Jul 8.