To compare TFO manufacturing processes between two different methods of design: 1) remotely and digitally designed by an expert team located at Leon Berard Hospital in Hyères, France and 2) designed manually and on-site by the local Haitian expert team.
Patients ≥5 years old with face and/or neck burns, with or at risk of skin complications, were recruited at the MSF Hospital of Tabare, Haïti. After getting a digital surface scan of the face/neck, each patient received two TFOs created from the two different methods. Both TFOs were produced using 3D printed molds to create plaster positives that are then used to thermoform transparent PETG plastic to obtain the TFO. Both versions were assessed on each patient for clinical validation in a blinded manner. Criteria of fitting included appropriate pressure on burn area, absence of excess pressure regions and overall lack of pain. If a TFO didn’t match all criteria, the local physiotherapist would perform iterative modifications on the TFO to adjust the applied pressure. The number of iterations were recorded and timed. Instances of validated fit at first trial and the number of iterations were analyzed.
A total of 31 patients were included during a 2 year recruitment period, with 26 patients completing the study protocol and 5 patients unable to return to the hospital after inclusion due to severe security conditions.
Remotely designed TFO resulted in a greater rate of validation at initial fitting (21/26, 80.8%) compared to those designed locally using the manual design method (18/26, 69.2%).
When iterative modifications were needed after first fit, remotely designed TFO (5/26) required a median (Interquartile Range) of 20 (20-60) minutes of total modification, while manually designed TFO (8/26) required 26 (18-68) minutes of total modification.
Remotely designed TFO seems to be an efficient method to achieve validated fit by leveraging tele-rehabilitation or remote support from global experts. These digital methods could be implemented in other contexts to expand access to TFO for burn patients globally.
Provision of TFO for burn patients in humanitarian contexts requires comprehensive rehabilitation care including appropriate physiotherapy follow-up. The digital design method enables progressive training with remote support to field colleagues with the goal of becoming fully autonomous in efficiently providing TFO to their burn patients.
Orthotics
Humanitarian
