Back to resultsInvestigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions
Primary Purpose
Chronic and Non-healing Wounds
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
3d camera
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic and Non-healing Wounds
Eligibility Criteria
Inclusion Criteria:
- Patients must have a non-healing wound and be over 18 years of age the criteria for non-healing wounds is as per 5.1 on the community nursing referral criteria when considering referral of patients to tissue viability:
'would expect that the wounds are deteriorating, chronic, non-healing or static or there are problems with the dressing regime'
Patients must be willing to provide written informed consent
Patients must have a registered Sheffield General Practitioner and be referred to tissue viability for a static or deteriorating wound
Exclusion Criteria:
- Patients with circumferential leg ulcers
Patients with deep narrow sinus where the opening is less than 10mm
Wounds on the face where the image would include the eyes or distinguishing features
Patients unable to provide written informed consent.
Sites / Locations
- Sheffield Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
3d camera
Arm Description
3d camera
Outcomes
Primary Outcome Measures
comparative consistency of the image
comparative reliability and consistency of the image between 2d and 3d images
comparative consistency of the measurement
comparative reliability and consistency of the measurements between 2d and 3d images
Secondary Outcome Measures
Full Information
NCT ID
NCT03355599
First Posted
November 22, 2017
Last Updated
February 12, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03355599
Brief Title
Investigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions
Official Title
Investigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
December 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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 study will explore whether a 3D camera data can provide a more accurate baseline measurement (compared to 2D images with manual measurement) to support better clinical decision making in referrals to tissue viability.
Detailed Description
Chronic and non-healing wounds are a significant problem to manage in community and represent a significant workload in community nursing. The current management for non-healing wounds includes referral to the tissue viability service, using a 2 D photographic image with assessment information. This study will pilot the use of a 3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention. The introduction of 3 D measurement and monitoring of wounds will be compared with usual care. With a target recruitment of 30 patients via tissue viability, the pilot will report on the feasibility of using this outcome measure and the effectiveness of monitoring on wound closure or improvement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic and Non-healing Wounds
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3d camera
Arm Type
Other
Arm Description
3d camera
Intervention Type
Other
Intervention Name(s)
3d camera
Intervention Description
3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention
Primary Outcome Measure Information:
Title
comparative consistency of the image
Description
comparative reliability and consistency of the image between 2d and 3d images
Time Frame
1 week
Title
comparative consistency of the measurement
Description
comparative reliability and consistency of the measurements between 2d and 3d images
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have a non-healing wound and be over 18 years of age the criteria for non-healing wounds is as per 5.1 on the community nursing referral criteria when considering referral of patients to tissue viability:
'would expect that the wounds are deteriorating, chronic, non-healing or static or there are problems with the dressing regime'
Patients must be willing to provide written informed consent
Patients must have a registered Sheffield General Practitioner and be referred to tissue viability for a static or deteriorating wound
Exclusion Criteria:
Patients with circumferential leg ulcers
Patients with deep narrow sinus where the opening is less than 10mm
Wounds on the face where the image would include the eyes or distinguishing features
Patients unable to provide written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda King
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Investigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions
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