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Trial of Abscess Drainage Techniques

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ClinicalTrials.gov Identifier: NCT02545946
Recruitment Status : Suspended (Staff changes)
First Posted : September 10, 2015
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Cutaneous Abscess Device: vessel loop Other: traditional I&D with or without packing Not Applicable

Detailed Description:

This prospective randomized single blind clinical trial will be conducted in a suburban pediatric emergency department that treats approximately 29,000 patients per year. Patients between 0-17 years with a superficial skin or soft tissue abscess larger than 3 cm that would be appropriate for ED I&D and outpatient management will be screened for inclusion. Patients will be excluded if they are immunocompromised (taking chemotherapy, steroid or bioactive medications or having diabetes mellitus), require a subspecialist for drainage or require hospitalization. Subjects will be required to provide assent when age-appropriate, and parental consent will be obtained. The parent or guardian will need to be in the emergency department with the child to provide consent. Subjects will be randomized to be in either the traditional I&D arm or the minimally invasive vessel loop arm using numbered sealed envelops. Computer blocking will randomize these numbered envelopes. Inside the envelope there will be instructions to the treating physician as to which of two standard techniques should be employed.

  • Standardized I&D will be performed with a #11 blade scalpel and a full thickness cut incising the lesion along at least 50% of the abscess diameter. The pocket will then be probed to break up septations and the residual cavity will be irrigated with normal saline. Iodinated gauze 0.25 inch will be used to loosely pack the remaining cavity if the physician deems packing is necessary. The gauze will be left trailing out of the surgical incision. The abscess will then be covered with 4 X 4 dry gauze and taped in place.
  • Minimally invasive I&D with vessel loop will be preformed by making a 5mm incision with a #11 blade in the area of maximal fluctuance. The cavity will then be probed with forceps breaking up any septations. The forceps will then be used to find the furthest extent of the cavity, and the #11 blade will be used to make a 5mm incision at the tip of the forceps (at the farthest extent of the cavity). The forceps will then be pushed through this second incision. The vessel loop will be grasped by the forceps and then pulled back through both surgical incisions. The vessel loop will then be tied loosely together, creating a loop back through both surgical incisions. Both sides of the incisions will then be irrigated with normal saline.

Cultures will be obtained, if possible, from the abscess. Pain medication and sedation at the time of the I&D will be left to the discretion of the treating physician. Antibiotics will not be mandated, but allowed at the judgment of the treating medical team. All subjects will be given 2 prescriptions for analgesia at home. One for mild pain, ibuprofen; another for moderate or severe pain, acetaminophen with hydrocodone (either liquid or pills) will be given. Equipotent alternatives will be provided in case of medication allergy. Pain scores will be assessed using a ten point scale before and after the procedure and at 48 hour follow up. Data recorded at the first visit will include demographics (age, male/female), characteristics of the abscess, fever, duration of symptoms, history of prior abscess, antibiotics in the last month, and provision of antibiotics post-procedure.

All subjects will return to the ER in 72 hours and 1 week for a recheck. At the 3rd day visit, wound packing will be removed. Large cavities will be repacked at the discretion of the ED physician. Loops will be cut and removed at the 7th day visit unless significant cellulitis remains. If cellulitis remains after 7 days, additional visits/hospitalization would be set up at the treating doctors discretion. Given that failure of treatment is a possible event in any abscess drainage, even those not involved with this study, hospitalization or additional visits beyond the 2 included in the study, will be billed to the patient's family and/or insurance company as any visit to the ER or hospital admission.

Patients and families will also be contacted at one month via telephone interview. Self-rated cosmetic outcome will be assessed using a 10 point scale from worst to best looking scar.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Control Trial.
Actual Study Start Date : October 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Active Comparator: Traditional
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
abscess will be drained with a traditional I&D with or without packing (as deemed appropriate by ER doctor)

Active Comparator: Minimally Invasive
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
using the vessel loop to hold the place of the surgical wound that is made during I&D




Primary Outcome Measures :
  1. number of patients who require repeat I&D collected by data form [ Time Frame: 1 week ]
    any patient that needs an additional I&D procedure noted on data collection forms

  2. Number of patients who Need to have an antibiotic added to treatment plan/or changed antibiotic after the initial visit collected by data form [ Time Frame: 1 week ]
    any patient requiring the above noted on data collection forms

  3. the number of patients who need to be hospitalized after the first visit collected by data form [ Time Frame: 1 week ]
    if patient is hospitalized after first visit, as collected on data form


Secondary Outcome Measures :
  1. patient satisfaction with procedure collected by survey [ Time Frame: 1 day ]
    1-100 scale of satisfaction survey with the drainage performed

  2. patient satisfaction with healing of abscess collected by survey [ Time Frame: 1 month ]
    1-100 scale survey of how satisfied patient is with how the drainage site healed

  3. patient satisfaction with overall treatment of the abscess collected by survey [ Time Frame: 1 month ]
    1-100 scale survey for how satisfied patient is with overall care related to abscess



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545946


Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Milan Nadkarni, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02545946     History of Changes
Other Study ID Numbers: IRB00033369
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
traditional incision and drainage
minimally invasive incision and drainage
vessel loop
emergency department
pediatrics

Additional relevant MeSH terms:
Abscess
Skin Diseases
Suppuration
Infection
Inflammation
Pathologic Processes
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs