Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery

NCT03285061 | Completed Results FDA Device

• 1 other identifier: 2017P002031
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Disposal; Behavior

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Safely Disposed The Excess Medication

  Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.

  6 weeks

Study Arms (2)

Standard Disposal Instructions

NO INTERVENTION

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.

At Home Disposal

EXPERIMENTAL

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

Interventions

Deterra Drug Deactivation System 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.

At Home Disposal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

Related Links

• Deactivation System Website

MeSH Terms

Conditions

Behavior

Limitations and Caveats

* Single site study: results may not be replicable in other settings or in patients undergoing other procedures * Potential for reporting bias * Patients may have felt social pressure to properly dispose of medication * Since the time of this study, the FDA has conditionally endorsed flushing unused dangerous medications down the toilet in instances in which a take back location is not available. * Amounts initially prescribed and leftover were not recorded

Results Point of Contact

• Title: Dr. Christopher Chiodo
• Organization: Brigham & Women's Hospital

cchiodo@bwh.harvard.edu

617-983-7363

Study Officials

• Christopher Chiodo, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Orthopedic Surgeon and Chief of the Foot and Ankle Service at the Brigham and Women's and Faulkner Hospitals

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 15, 2017
• Study Start: October 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 6, 2021
• Results First Posted: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)