NCT02822768

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

9.7 years

First QC Date

June 30, 2016

Last Update Submit

January 22, 2026

Conditions

Cutaneous Abscess

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients needing further treatment

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

    14 days

Secondary Outcomes (1)

  • Visual Analog Scale for Pain (VAS pain) post procedure

    14 days

Study Arms (2)

Packing

ACTIVE COMPARATOR

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.

Procedure: Packing

No packing

PLACEBO COMPARATOR

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

Other: No packing

Interventions

PackingPROCEDURE

The patient will receive packing as part of their wound care

Packing
No packingOTHER

The patient will not receive packing as part of their wound care

No packing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93701, United States

RECRUITING

Related Publications (7)

  • 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: 19388915BACKGROUND

  • 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.

    PMID: 9137156BACKGROUND

  • 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.

    PMID: 3881155BACKGROUND

  • 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.

    PMID: 3069102BACKGROUND

  • 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.

    PMID: 6805714BACKGROUND

  • 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.

    PMID: 3324596BACKGROUND

  • 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.

    PMID: 15486749BACKGROUND

MeSH Terms

Interventions

Drug Packaging

Intervention Hierarchy (Ancestors)

Technology, PharmaceuticalInvestigative TechniquesDrug IndustryManufacturing IndustryIndustryTechnology, Industry, and AgricultureProduct Packaging

Study Officials

  • Michael Darracq, MD, MPH

    UCSF - Fresno

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Darracq, MD, MPH

CONTACT

559-499-6440mdarracq@fresno.ucsf.edu

Jannet Castaneda, BA

CONTACT

559-499-6435jcastaneda@fresno.ucsf.edu

Study Design

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

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 4, 2016

Study Start

August 1, 2016

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)