Investigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions

February 12, 2019 updated by: Sheffield Teaching Hospitals NHS Foundation Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 3d camera
Other: 3d camera
3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparative consistency of the image
Time Frame: 1 week
comparative reliability and consistency of the image between 2d and 3d images
1 week
comparative consistency of the measurement
Time Frame: 1 week
comparative reliability and consistency of the measurements between 2d and 3d images
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Brenda King, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2017

Primary Completion (ACTUAL)

December 29, 2017

Study Completion (ACTUAL)

December 29, 2017

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (ACTUAL)

November 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH19655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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