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Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery

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ClinicalTrials.gov Identifier: NCT03285061
Recruitment Status : Completed
First Posted : September 15, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Chiodo, Brigham and Women's Hospital

Brief Summary:
This study aims to survey the drug disposal methods of orthopedic foot and ankle patients with excess pain medication following and operation. The study is a randomized control trial comparing the use of FDA approved at home disposal methods to current clinical methods of recommending disposal at medication drop off locations.

Condition or disease Intervention/treatment Phase
Medication Disposal Behavior Device: Deterra Drug Deactivation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
No Intervention: Standard Disposal Instructions
These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
Experimental: At Home Disposal
With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
Device: Deterra Drug Deactivation System
A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.




Primary Outcome Measures :
  1. Patients' Drug Disposal Methods using a survey [ Time Frame: 6 weeks ]
    Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • This study will include foot and ankle orthopedic patients at Brigham and Women's Hospital undergoing a surgical procedure.

Exclusion Criteria:

  • Those under age 18 will be excluded from this study, as their variation in care could affect the data. We will also exclude adults with impaired decision-making capacity and adults who take methadone or have a history of prior opioid dependence.

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): NCT03285061


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Christopher Chiodo, MD Brigham and Women's Hospital

Additional Information:
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Responsible Party: Christopher Chiodo, Attending Orthopedic Surgeon and Chief of the Foot and Ankle Service at the Brigham and Women's and Faulkner Hospitals, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03285061     History of Changes
Other Study ID Numbers: 2017P002031
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers or organizations.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes