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Use of a Compression Device for Ring Removal: A Prospective Trial

Primary Purpose

Wounds and Injuries, Hand Injuries, Device Malfunction

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Compression device.
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals presenting to the QEII emergency department with a chief complaint of a stuck ring on a finger, or with heath conditions that necessitate removal of a ring that cannot be removed without clinician assistance.

Exclusion Criteria:

  • Contraindications to compression device use including certain bone, nerve or blood vessel conditions.

Sites / Locations

  • Dalhousie University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

Individuals requiring ring removal.

Outcomes

Primary Outcome Measures

Number of patients with successful ring removal using a compression device
Successful ring removal with compression device

Secondary Outcome Measures

Full Information

First Posted
October 14, 2020
Last Updated
January 24, 2021
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT04728607
Brief Title
Use of a Compression Device for Ring Removal: A Prospective Trial
Official Title
Use of a Compression Device for Ring Removal: A Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The usual treatment for stuck rings includes a variety of techniques including use of ice to reduce swelling, use of lubricants, and sometimes the use of string or ring cutters. The success rate of these techniques is variable and cutting the ring is usually reserved as a last resort. Sometimes removal of a ring can take time, and can cause some small injury to the patient. Because of this, it is important to consider other methods for ring removal. This study is looking at using a device that uses compression to reduce swelling of the finger causing the ring to be stuck. This device has been approved for use in Canada. The purpose of this study is to evaluate how effective a compression device is at removing stuck rings. The study question is: how effective is a compression device at removing stuck rings? A Compression Device (CD) is a device that uses circumferential compression to reduce swelling around a stuck ring. The device is used by placing it near, but not over-top, the offending ring, and then is inflated compressing the finger. The device is applied, and the hand elevated, for approximately five minutes. The device is then removed, and with a small amount of lubricant, the ring is removed. All patients requiring ring removal at the QEII emergency department, if a compression device can be used safely, will be asked if they would like to be included in the study and have their ring removal attempted by a compression device. Following removal attempt, the clinician will document information about the ring removal. This will include some questions regarding the patient's experience with the removal. No identifying information or personal health information will be recorded. The investigators plan to collect information about use of the compression device for a period of one year. Following this time, the data will be analyzed to determine how effective the compression device is at removing rings including statements regarding patient experience. This information will be documented in a manuscript intended for publication and may be presented at academic conferences or other continuing education events. The investigators will be measuring the success rate of ring removal with the compression device. In addition, the investigators will record information on any side effects of use of the compression device, as well as patient experience including pain and satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Hand Injuries, Device Malfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
Individuals requiring ring removal.
Intervention Type
Device
Intervention Name(s)
Compression device.
Intervention Description
A compression device is a device that uses circumferential compression to reduce swelling around a stuck ring. The device is used by placing it near, but not overtop, the offending ring, and then is inflated compressing the finger. The device is applied, and the hand elevated, for approximately five minutes. The device is then removed, and with a small amount of lubricant, the ring is removed.
Primary Outcome Measure Information:
Title
Number of patients with successful ring removal using a compression device
Description
Successful ring removal with compression device
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals presenting to the QEII emergency department with a chief complaint of a stuck ring on a finger, or with heath conditions that necessitate removal of a ring that cannot be removed without clinician assistance. Exclusion Criteria: Contraindications to compression device use including certain bone, nerve or blood vessel conditions.
Facility Information:
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis J Staple, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of a Compression Device for Ring Removal: A Prospective Trial

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