Packing Versus no Packing for Cutaneous Abscess

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Cutaneous Abscess

Treatments: Other: No packing; Procedure: Packing

Study type: Interventional

Funder types: Other

Identifiers

NCT02822768

2016052

Details and patient eligibility

About

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.

Full 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

Enrollment: 196 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups, including a placebo group

Packing

Active Comparator group

Description:

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.

Treatment:

Procedure: Packing

No packing

Placebo Comparator group

Description:

The patient is not to have packing of the abscess as part of the incision and drainage procedure

Treatment:

Other: No packing