Burn Clinical Trial
Official title:
Flexible Hydrogel Nanoparticle Wound Dressing Allows Greater Joint Range of Motion Compared to Typical Sodium Carboxymethylcellulose Dressing
The objective of this study is to evaluate the difference in joint range of motion of a new flexible hydrogel nanoparticle wound dressing compared to typical sodium carboxymethylcellulose dressing Aquacel AG for treatment of partial thickness burns.
This is a single center, randomized, single blind therapeutic exploratory study to monitor
the range of motion of wounds treated with the new nanoparticle hydrogel dressing compared
to the range of motion of wounds treated with existing treatment standard (sodium
carboxymethylcellulose dressing) in patients with partial thickness burns. A total of 50
joints will be studied. The patients will be at least 7 years of age.. The Department of
Physical Medicine and Rehabilitation at Parkland Hospital and Health System, UT
Southwestern, will be asked to enroll enough patients to meet the proposed 50 joint study
sites (approximately 3-5 afflicted joints per patient). Children will be included in the
patient population if possible. Inclusion criteria for the medical condition will be at
least one partial thickness burn that crosses at least one peripheral joint axial to the
proximal interphalangeal joints. As a control, the patients will also need to have an
unburned contralateral joint without major internal or external joint derangement.
The Primary Investigator will first identify the study site and control site for each
patient and take the initial measurements. Trained personnel will apply the bandage to the
study site. No secondary bandage will be applied. Typical meticulous wound care and adequate
analgesic medical coverage will be provided for the duration of the study. Both the patient
and medical staff will be trained on patient use instructions for the dressing. The patients
will be monitored for a short time after application of the bandage as part of standard
procedure, and the patient is then allowed to go home with instructions for care. Within 2-8
days after application, the dressing will be inspected and range of motion will be measured
for both the study site and the control site. Any concomitant treatment (medications, wound
care) will be thoroughly documented for the duration of the study. Both dressings are
designed to remain on the wound until the bandage falls off, which indicates
re-epithelialization of the wound. The dressings should not be removed by the patient or
medical staff unless there are signs of infection, deterioration of bandage, or other
adverse event. If the bandage falls off, the patient is instructed to immediately call the
medical staff.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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