Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00746109
Other study ID # 08-143
Secondary ID
Status Completed
Phase Phase 4
First received September 2, 2008
Last updated January 3, 2011
Start date September 2008
Est. completion date March 2010

Study information

Verified date January 2011
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 24 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
United States New York University / Bellevue Hospital Center NY New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healing (resolution, cosmesis, complications and recurrence) one month Yes
Primary Ultrasound test characteristics day one No
Secondary Parental/patient satisfaction one month No
Secondary Cost-effectiveness one month No
See also
  Status Clinical Trial Phase
Completed NCT02865902 - Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness N/A
Completed NCT01227759 - Tyrosur® Gel-Investigation on Wound Healing Efficacy Phase 2
Terminated NCT01191567 - Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life N/A
Recruiting NCT00737425 - Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery Phase 4
Terminated NCT00762138 - The AutoloGelâ„¢ Post-Market Surveillance (TAPS) Program N/A
Withdrawn NCT00234559 - Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT05588583 - A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. N/A
Completed NCT02591537 - OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University N/A
Completed NCT00792688 - Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation Phase 2
Recruiting NCT05608317 - A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing N/A
Recruiting NCT02195063 - Survey Study for Pain Management, Wound Care, Scar Care or UDT Phase 4
Completed NCT01319149 - A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes N/A
Completed NCT00153452 - Workplace Productivity of Persons Who Use Controlling Behavior With Intimate Partners N/A
Completed NCT06083740 - A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
Not yet recruiting NCT02672280 - Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects Phase 1/Phase 2
Withdrawn NCT02314416 - Stem Cells In Wound Healing With Collagen Matrix as a Carrier Phase 4
Recruiting NCT01454167 - Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications N/A
Completed NCT01921725 - The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing N/A