Study of Wound Packing After Superficial Skin Abscess Drainage

NCT00746109 | Completed Phase 4 DMC

• 1 other identifier: 08-143
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

randomized; clinical trial; ultrasound; prospective; abscess; packing; incision and drainage; superficial soft tissue infection

Outcome Measures

Primary Outcomes (2)

• Healing (resolution, cosmesis, complications and recurrence)

  one month

• Ultrasound test characteristics

  day one

Secondary Outcomes (2)

• Parental/patient satisfaction

  one month

• Cost-effectiveness

  one month

Study Arms (2)

NOPACKING

PLACEBO COMPARATOR

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

Procedure: NoPacking

PACKING

EXPERIMENTAL

This group will receive wound packing as per usual protocol

Procedure: Wound packing

Interventions

Wound packing PROCEDURE

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

PACKING

NoPacking 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.

NOPACKING

Eligibility Criteria

• Age: 1 Year - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University / Bellevue Hospital Center

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 22653459 DERIVED

MeSH Terms

Conditions

Abscess; Skin Diseases, Infectious; Furunculosis; Carbuncle; Folliculitis; Cellulitis; Wounds and Injuries; Surgical Wound

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Bacterial; Fish Diseases; Animal Diseases; Hair Diseases; Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 4, 2011

Record last verified: 2011-01

Locations

US (1)