Early Identification of Suspected Deep Tissue Injury (sDTI)

• Conditions: Pressure Ulcer; Bed Sore
• Interventions: Other: No Intervention

• Registration Number: NCT02705443
• Lead Sponsor: Wound Vision

Brief Summary

The purpose of this study is to further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or lack thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures (temperature). These signatures will be measured and quantitatively recorded using long-wave infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their pathophysiological evolution. Additionally, the LWIT physiological data will be cross-compared to the gold standard of visual assessment and other current standards of wound evaluation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02
• Primary Completion: 2017-05
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18 years of age or older
• Can tolerate position changes ≥ 10 minutes
• Non-pregnant

Exclusion Criteria

• Therapies/treatments cannot be safely suspended to for an imaging session
• Non-English speaking

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tissue w/ Thermographic Anomaly	No Intervention	* Visibly undamaged tissue with anomaly identified by the thermographic image * No intervention * Standard of care
Tissue w/o Thermographic Anomaly	No Intervention	* Visibly undamaged tissue with no anomaly identified by the thermographic image * No intervention * Standard of care
Tissue w/ Visible Anomaly	No Intervention	* Visibly damaged tissue * No intervention * Standard of care

Primary Outcome Measures

Name	Time	Method
Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer	Up to 25 days	Sensitivity and specificity of a thermographic anomaly that progresses to a stageable pressure ulcer
Number of anatomical areas with intact skin and a thermographic anomaly that do not progress to a stageable pressure ulcer	Up to 25 days	Sensitivity and specificity of a thermographic anomaly that does not progress to a stageable pressure ulcer

Secondary Outcome Measures

Name	Time	Method
Temperature change associated with anatomical areas after a stageable pressure ulcer occurs	Up to 25 days

Trial Locations

Locations (1)

Kindred Hospital Dayton; 🇺🇸 Dayton, Ohio, United States