Impact of a Clinical Decision Algorithm on Length of Hospital Stay and Costs of Care of Burned Patients

NCT03876340 | Unknown DMC

• 1 other identifier: QX2018
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Reliable and valid assessment of burn wound depth or healing potential is essential to treatment decision-making, to provide a prognosis, and to compare studies evaluating different treatment modalities. Clinical evaluation remains the most widely used method for assessing the depth of the burn wound. This method is based on the subjective evaluation of visual and tactile characteristics of the wound, with an accuracy ranging between 50 to 70%; which is not precise to guide clinical decision making. The aim of these study is to validate thermography as a therapeutic approach to predict treatment modality based on thermographic imaging of the wound and its healing potential obtained during the first three days of treatment of either healing by re-epithelization, requiring skin grafts, or requiring amputations. By performing this algorithm, it is expected to address three aspects of the management of patients with acute burns: early clinical diagnosis, initial management decisions and reduction of hospitalization days.

Conditions

Burns

Keywords

Burns; Cost-effectiveness; Clinical decision rule; Length of stay; Cost of treatment

Outcome Measures

Primary Outcomes (2)

• Length of stay

  Number of days the patient stays in the burn care unit

  Through study completion, an average of 30 days

• Treatment modality conversion

  Change of the initial treatment modality

  Through study completion, an average of 30 days

Secondary Outcomes (2)

• Rate of complications

  Through study completion, an average of 30 days

• Cost of stay

  Through study completion, an average of 30 days

Study Arms (2)

Current treatment

ACTIVE COMPARATOR

Patients will receive burn care treatment as dictated by the surgical team (current standard of care).

Other: Current treatment

Algorithm-dictated treatment

EXPERIMENTAL

Patients will receive burn care treatment as dictated by the treatment algorithm (PLOS ONE 13(11): e0206477.).

Other: Treatment algorithm

Interventions

Treatment algorithm OTHER

Digital infrared thermograms will be obtained during the first contact with the patients. Temperature recordings of the injured and healthy skin will be used to calculate the temperature difference between the structures. The thermograms will be used to dictate the initial treatment.

Algorithm-dictated treatment

Current treatment OTHER

Digital infrared thermograms will be obtained during the first contact with the patients. Temperature recordings of the injured and healthy skin will be used to calculate the temperature difference between the structures, but the results will be kept sealed until the study is finished. The patients will receive the usual standard of care as dictated by the surgical team.

Current treatment

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with partial or full thickness burn in \<15% of the total body surface area in distal limbs, including hands or feet.
• Patients admitted to the burn care unit within 24 hours from injury.
• Patients that signed the informed consent. In the case of children or patients unable to consent themselves, signing of the consent by their guardian.

You may not qualify if:

• Patients who sustained electrical burns.
• Patients that received previous care in any other unit.
• Patients with uncontrolled chronic diseases.
• Patients that used corticosteroids or cytotoxic medications within 3 months of sustaining the injury.
• Patients with a baseline body mass index of \<19.9 for adults or below the 5th percentile for their age in children.
• Presence of foreign bodies embedded in the wound tissue, gross edema, systemic causes of distal hypoperfusion, or presence of local infection.

Sponsors & Collaborators

• Hospital Central "Dr. Ignacio Morones Prieto": lead

Study Sites (1)

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, 78290, Mexico

Location

Related Publications (3)

• Martinez-Jimenez MA, Ramirez-GarciaLuna JL, Kolosovas-Machuca ES, Drager J, Gonzalez FJ. Development and validation of an algorithm to predict the treatment modality of burn wounds using thermographic scans: Prospective cohort study. PLoS One. 2018 Nov 14;13(11):e0206477. doi: 10.1371/journal.pone.0206477. eCollection 2018.

  PMID: 30427892 BACKGROUND

• Medina-Preciado JD, Kolosovas-Machuca ES, Velez-Gomez E, Miranda-Altamirano A, Gonzalez FJ. Noninvasive determination of burn depth in children by digital infrared thermal imaging. J Biomed Opt. 2013 Jun;18(6):061204. doi: 10.1117/1.JBO.18.6.061204.

  PMID: 23111601 BACKGROUND

• Kolosovas-Machuca ES, Gonzalez FJ. Distribution of skin temperature in Mexican children. Skin Res Technol. 2011 Aug;17(3):326-31. doi: 10.1111/j.1600-0846.2011.00501.x. Epub 2011 Feb 22.

  PMID: 21338404 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jose L Ramirez Garcia Luna, MD, MSc

  Universidad Autonoma de San Luis Potosi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Controlled double blinded study. Patients and outcomes assessors will be masked to intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Burn Unit

Model Details: Two parallel arms: group A will receive treatment as usual, group B will receive treatment as dictated by a clinical decision algorithm (PLoS ONE 2018:13(11):e0206477).

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 15, 2019
• Study Start: November 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: August 31, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)