Packing Versus no Packing for Cutaneous Abscess

Cutaneous Abscess Clinical Trial

Official title:

Is Routine Packing of Cutaneous Abscesses Necessary?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02822768
• Other study ID #: 2016052
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 2024

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: Michael Darracq, MD, MPH
• Phone: 559-499-6440
• Email: mdarracq[@]fresno.ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Cutaneous Abscess
• Skin Diseases

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

Locations

Country	Name	City	State
United States	Community Regional Medical Center	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients needing further treatment	follow-up call to determine if patient required further treatment beyond routine care	14 days
Secondary	Visual Analog Scale for Pain (VAS pain) post procedure	Measure pain score after procedure	14 days