NCT05019144: TOBI

Telemedicine Optimized Burn Intervention

Completed NA Results posted Last updated 11 July 2025

What this trial tests

NA trial testing Face-to-face burn care in Burns in 130 participants. Completed in 8 March 2024.

Timeline

1 June 2022

Primary endpoint
8 March 2024

8 March 2024

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	130
Start date	1 June 2022
Primary completion	8 March 2024
Estimated completion	8 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Face-to-face burn care
• Telemedicine enhanced burn care

Conditions studied

• Burns — all drugs for Burns →
• Pediatric ALL — all drugs for Pediatric ALL →

Sponsor

Medical University of South Carolina

Who can join

Adults 0 to 80, any sex, with Burns or Pediatric ALL. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Agree to Participate in the Study Primary · At enrollment

Looking at the number of participants (parents and children) who agree to enroll in the study at the time of burn injury versus the total number of participants who were approached to participate in the study.

Group	Value	95% CI
Face-to-face Arm	66
TOBI Arm	64

Number of Participants Retained in the Study Over Time Primary · From enrollment to 30 days after burn wound has healed (up to 35 days after enrollment).

Looking at the number of participants retained in the study versus those lost to attrition

Group	Value	95% CI
Face-to-face Arm	36
TOBI Arm	42

Wound Care Treatment Adherence Primary · Assessed weekly at clinic/telemedicine visit until burn wound was healed, up to 35 days after injury

Looking at the percentage of patient/caregiver dyads who adhered to prescribed burn wound care treatment protocol. A wound care fidelity checklist was used at each visit to determine the percentage of wound care adherence per visit. These percentages were then averaged for each weekly visit to give the value below.

Group	Value	95% CI
Face-to-face Arm	76.8	± 40.1
TOBI Arm	84.9	± 29.1

Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems Primary · Assessed weekly until burn wound was healed, up to 35 days

Looking at the number of child participants in each condition that experienced adverse events, serious adverse events, and unexpected problems. Adverse events in this study included infection, delay in wound care or non-healing wound. Adult caregivers are not included in this as they did not have burn wounds that were assesssed.

Group	Value	95% CI
Face-to-face Arm	0
TOBI Arm	0

Number of Times Problems With Technology Happened in the TOBI Condition Primary · Assessed weekly until burn wound was healed, up to 35 days

Looking at the number of times providers or participants experienced and reported technological problems with TOBI

Group	Value	95% CI
TOBI Arm	1

Number of Days Until Wound is Healed Secondary · Measured during the treatment phase (2-4 weeks)

Looking at the number of days it takes for wound to heal following burn injury in both conditions

Group	Value	95% CI
Face-to-face Arm	11.5	± 4.3
TOBI Arm	11.4	± 3.9

Number of Unscheduled ED or Clinic Visits Secondary · Measured during the treatment phase (2-4 weeks)

Looking at the number of times participants had unscheduled visits (in the ED or the clinic)

Group	Value	95% CI
Face-to-face Arm	0
TOBI Arm	2

Number of Wound Complications Secondary · Measured during the treatment phase (2-4 weeks)

Looking at the number of wound complications (e.g., infection, conversion to deeper burn requiring surgery, conversion to deeper burn requiring a change in therapy).

Group	Value	95% CI
Face-to-face Arm	0
TOBI Arm	0

Patient-reported Pain Scores Secondary · Measured during the treatment phase (week 1 clinic visit)

Looking at average pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most patients only attended one follow up visit but if more than one, the average score is reported below.

Group	Value	95% CI
Face-to-face Arm	3.1	± 3
TOBI Arm	1.8	± 1.7

Caregiver's Perception of Child's Pain Scores Secondary · Measured during the treatment phase (week 1 clinic visit)

Looking at average caregiver's perception of child's pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most dyads only attended one follow up visit but if more than one, the average score is reported below.

Group	Value	95% CI
Face-to-face Arm	3.1	± 3.0
TOBI Arm	1.8	± 1.7

Attitudes Towards Technology and Telemedicine Questionnaire Secondary · Measured at baseline and 1-month follow-up

Looking at the change in group average scores on the Attitudes Towards Technology and Telemedicine Questionnaire (caregiver-reported) from baseline to 1 month follow-up. Scores may range between 26-130, with higher scores = more positive attitudes towards technology and telemedicine.

Group	Value	95% CI
Face-to-face Arm	79.5	± 6.3
TOBI Arm	78.0	± 8.4

Perception of Healthcare Access Secondary · Measured at baseline and 1-month follow-up

Looking at the change in group average scores on the Barriers to Care Questionnaire (BCQ), Pragmatics Subscale (caregiver-reported). Scores range from 0-100, with higher scores = fewer barriers and problems with access.

Group	Value	95% CI
Face-to-face Arm	64.5	± 25.5
TOBI Arm	72.6	± 20.3

Adverse events — posted to ClinicalTrials.gov

Time frame: For each child participant dyad, adverse event data was only collected on the child participant up to 46 days after burn wound injury.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Face-to-face Arm

Serious: 0/33 (0%)

Deaths: 0/33

TOBI Arm

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (1 terms — click to expand)

Reaction	System	Face-to-face Arm	TOBI Arm
Unscheduled visit to the ED or Clinic	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT05019144 adverse events section.

Sponsor's own description

Because burn patients and their caregivers often live long distances from regional burn centers, access to expert burn care is limited, resulting in a negative effect on adherence to treatment and a higher risk of wound complication. A novel smartphone application synchronized with a web portal for providers, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging, image transfer, and video-conferencing. The goal of the present study is evaluate TOBI compared to face-to-face care as usual for pediatric patients/caregivers visiting a burn center. This study will also assess the feasibility of conducting a larger-scale clinical trial in several burn centers. The app will allow the physician and patient/caregivers to make instant decisions regarding treatment, allowing for "turn on a dime" treatment decisions, rather than having the patients and families wait for scheduled clinic appointments, often hours away from home. This "on demand" medical care takes an innovative approach to increasing access to burn experts through smartphone technology and addressing adherence to prescribed treatment by increasing communication between provider and patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.