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

Chronic and Non-healing Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355599
• Other study ID #: STH19655
• Status: Completed
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: December 29, 2017

Study information

• Verified date: February 2019
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic and Non-healing Wounds
• Wounds and Injuries

Intervention

Other:
• 3d camera
3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparative consistency of the image	comparative reliability and consistency of the image between 2d and 3d images	1 week
Primary	comparative consistency of the measurement	comparative reliability and consistency of the measurements between 2d and 3d images	1 week