Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery

NCT ID: NCT03285061

Last Updated: 2021-01-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Medication Disposal Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Deterra Drug Deactivation System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christopher Chiodo

Attending Orthopedic Surgeon and Chief of the Foot and Ankle Service at the Brigham and Women's and Faulkner Hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Chiodo, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://deterrasystem.com/

Deactivation System Website

Other Identifiers

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2017P002031

Identifier Type: -

Identifier Source: org_study_id

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