A Randomized Comparison Study of Minimally Invasive Loop Drainage Versus Standard Incision and Drainage for Skin Abscesses in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Seton Healthcare Family
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Treatment failure
Study Overview
Brief Summary
The purpose of this study is to compare abscess drainage utilizing the vessel loop technique in children to the standard incision and drainage technique with the endpoint to determine if rates of treatment failure are non-inferior.
Detailed Description
BACKGROUND INFORMATION:
Infections of skin and soft tissue remain one of the more common chief complaints in the pediatric emergency department. With methicillin-resistant Staphylococcus aureus being a prevalent pathogen, abscess development is not uncommon. The emergency department remains the common setting for required therapeutic intervention. However, active investigation exists in regard to the ideal intervention for children and adults.
Incision and drainage of cutaneous abscess has remained the standard of care for years. However this standard has been adopted without robust supportive evidence. Recently, various studies have questioned the benefit of various aspects of treatment, including antibiotics, incision size, and necessity for packing. Other studies have even suggested a less-invasive approach. Some of these have utilized a vessel loop and have demonstrated a reduced need for home-health visits, reduced inpatient length of stay, good patient tolerance, and no increase in failure rates. These studies are, however, retrospective in design with execution primarily by the surgical team.
STUDY DESCRIPTION:
Upon obtaining written informed consent/assent by the study team member, subjects will be randomized using a computerized randomization procedure and opaque envelopes. Initially, thorough history and physical exam will be performed. A data sheet will be completed detailing patient characteristics (eg. age, gender, ethnicity, prior treatment) and wound characteristics (eg. greatest diameter of both erythema and induration, presence of spontaneous drainage, location). Pain control/procedural sedation will be selected at the discretion of the treating physician, consistent with current local practice (eg. topical lidocaine, intranasal fentanyl and/or midazolam, oral acetaminophen/hydrocodone or ibuprofen, intravenous ketamine, morphine, or fentanyl). Pain will be assessed prior to physical exam and again shortly after the procedure via the validated FACES-Revised Pain Scale. The patient will provide this assessment if 5 years or older. Otherwise, the parent will provide the degree of pain perceived for their child. The difference between these two pain assessments will be evaluated as an endpoint. Physicians will report on their satisfaction with the procedure using a 5-point Likert scale.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 29 Days to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Physical findings suggestive of skin abscess warranting incision and drainage (determined by treating physician)
Exclusion Criteria
- •Abscess not suitable for drainage in the ED (eg. <1 cm induration, >15 cm induration)
- •Immunocompromised status (eg. diabetic patient or taking immunosuppressive medication)
- •Need for hospitalization following drainage
- •Abscess located above the clavicles or significantly involving genitals/pilonidal region
- •Previous instrumentation to the abscess
- •Primary language not English or Spanish
- •High probability of loss to follow up (parent does not commit to both mandatory follow up appointments)
Arms & Interventions
Control Arm
Receive standard incision and drainage
Intervention: Incision and Drainage (Procedure)
Intervention Arm
Receive minimal invasive loop drainage using the Vesi-loop device
Intervention: Vessel Loop Drainage (Procedure)
Outcomes
Primary Outcomes
Treatment failure
Time Frame: 14 days
Requiring reinstrumentation of abscess, or hospital admission for IV antibiotics
Secondary Outcomes
- Physician satisfaction with procedure(1 Day)
- Level of anxiety with wound care at home(14 Days)
- Parental satisfaction with procedure(1 Day)
- Cosmetic success(14 Days)
- Pain reduction with drainage procedure(1 Day)
- Parental satisfaction with scar(90 Days)
- Frequency of post-drainage visits to a physician(14 Days)
- Level of simplicity with wound care at home(14 Days)