Trial of Abscess Drainage Techniques

NCT02545946 | Completed

• 1 other identifier: IRB00033369
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparing the outcome of traditional incision and drainage with a larger skin incision with or without gauze packing of cutaneous abscess in pediatrics versus a new minimally invasive incision and drainage with two small incisions and a vessel loop transversing the incisions to keep them open.

Conditions

Cutaneous Abscess

Keywords

traditional incision and drainage; minimally invasive incision and drainage; vessel loop; emergency department; pediatrics

Outcome Measures

Primary Outcomes (3)

• number of patients who require repeat I&D collected by data form

  any patient that needs an additional I\&D procedure noted on data collection forms

  1 week

• Number of patients who Need to have an antibiotic added to treatment plan/or changed antibiotic after the initial visit collected by data form

  any patient requiring the above noted on data collection forms

  1 week

• the number of patients who need to be hospitalized after the first visit collected by data form

  if patient is hospitalized after first visit, as collected on data form

  1 week

Secondary Outcomes (3)

• patient satisfaction with procedure collected by survey

  1 day

• patient satisfaction with healing of abscess collected by survey

  1 month

• patient satisfaction with overall treatment of the abscess collected by survey

  1 month

Study Arms (2)

Traditional

ACTIVE COMPARATOR

cutaneous abscess with be opened in the traditional incision and drainage technique with large incision, breaking up of pockets of pus, washing out the pocket and with or without packing gauze placed into residual cavity

Other: traditional I&D with or without packing

Minimally Invasive

ACTIVE COMPARATOR

Cutaneous abscess will be opened with two small incisions just large enough to pass a vessel loop through both to keep them open. Pockets of pus will be broken up and the cavity washed out before placing the loop through both incisions and loosely tieing it over the skin

Device: vessel loop

Interventions

vessel loop DEVICE

using the vessel loop to hold the place of the surgical wound that is made during I\&D

Minimally Invasive

traditional I&D with or without packing OTHER

abscess will be drained with a traditional I\&D with or without packing (as deemed appropriate by ER doctor)

Traditional

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patient (0-18 years old) with abscess over 3 cm which can be drained in the ER and does not require hospitalization

You may not qualify if:

• Diabetes
• immunocompromised
• cancer
• chemotherapy
• requires hospitalization for treatment of abscess
• abscess felt not drainable in the ER by ER physicians

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Emergencies

Interventions

Drug Packaging

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging

Study Officials

• Milan Nadkarni, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: September 10, 2015
• Study Start: October 1, 2015
• Primary Completion: June 24, 2016
• Study Completion: July 7, 2016
• Last Updated: February 20, 2019

Record last verified: 2019-02