Study of Wound Packing After Superficial Skin Abscess Drainage

NCT ID: NCT00746109

Last Updated: 2011-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-03-31

Brief Summary

Superficial skin and soft tissue abscess are frequently managed by opening them up with a procedure called "incision and drainage". It is routine practice in the United States to place packing material inside the abscess cavity after opening them up, in order to promote better wound healing and limit abscess recurrence. However, this practice has never been systematically studied or proven to decrease complications or improve healing. Patients with wound packing usually return to the emergency room or practice setting for multiple "wound checks" and dressing/packing changes which lead to missed days from work or school and utilization of healthcare resources. This procedure can often be painful and may even require conscious sedation (and the risks entailed) especially in children. With rates of superficial skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it is important to determine whether packing wounds is necessary or even advantageous to patients.

This study is the first to systematically evaluate the efficacy of wound packing after superficial skin or soft tissue abscess incision and drainage in children. The investigators will be evaluating wound healing, complications, recurrence and pain associated with packing both short and long term. In addition, the investigators will also be evaluating the utility of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess cavity. This test may be useful to determine whether incision and drainage is necessary for an individual who has a skin infection that is suspicious for an abscess.

Conditions

Abscess; Skin Diseases, Infectious; Boils; Furuncle; Carbuncle; Folliculitis; Cellulitis; Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NOPACKING

The comparison group will undergo a routine incision and drainage procedure but will not have packing placed inside the abscess cavity.

Group Type: PLACEBO_COMPARATOR

NoPacking

Intervention Type: PROCEDURE

This is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity.

PACKING

This group will receive wound packing as per usual protocol

Group Type: EXPERIMENTAL

Wound packing

Intervention Type: PROCEDURE

1/4" non-iodoform packing loosely placed inside abscess cavity.

Interventions

Wound packing

1/4" non-iodoform packing loosely placed inside abscess cavity.

Intervention Type: PROCEDURE

NoPacking

This is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 1 - 24 years (i.e. any child seen in PED)
• Suspected abscess deemed to need incision & drainage by attending physician or fellow
• Size of abscess is greater than or equal to 1cm
• Parent or patient consent, and child assent

Exclusion Criteria

• Location of abscess on face, perianal, or genitals
• History of recurrent or chronic abscess
• Multiple abscesses requiring drainage at current visit
• Immunocompromised or unstable patient
• HIV, transplant recipient, immune deficiency syndrome
• immunosuppressive medications
• Wound already open/draining
• Previous participation in trial
• Patient will not be following up / managed by PES (e.g. surgical site)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

New York University School of Medicine

Locations

New York University / Bellevue Hospital Center

New York, New York, United States

Countries

United States

References

Kessler DO, Krantz A, Mojica M. Randomized trial comparing wound packing to no wound packing following incision and drainage of superficial skin abscesses in the pediatric emergency department. Pediatr Emerg Care. 2012 Jun;28(6):514-7. doi: 10.1097/PEC.0b013e3182587b20.

Reference Type: DERIVED

PMID: 22653459 (View on PubMed)

Other Identifiers

08-143

Identifier Type: -

Identifier Source: org_study_id