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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT01302457 -
Oral Care Study on Burn Patients
|
N/A | |
Completed |
NCT02729259 -
H2O VR for Burns 2015
|
N/A | |
Completed |
NCT01965340 -
Impact of Therapeutic Drug Monitoring on Anti-Infective Agents Amongst Severely Burned Patients Requiring ICU Admission
|
N/A | |
Withdrawn |
NCT01225107 -
Effect of Cranberry Extract on Infections in Burn Patients
|
N/A | |
Completed |
NCT01983280 -
The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients
|
N/A | |
Completed |
NCT00591448 -
Study in the Use of Virtual Reality as an Adjunct to Pain Control in Burn Patients
|
N/A | |
Active, not recruiting |
NCT02083900 -
Use of Banana Leaf Dressing on Donor Site Wounds
|
Phase 2 | |
Completed |
NCT00242970 -
Hypertrophic Scarring After Facial Burn
|
Phase 2 | |
Completed |
NCT00585325 -
Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes
|
N/A | |
Terminated |
NCT00591162 -
Bone Disease in Severely Burned Children
|
Phase 2/Phase 3 | |
Terminated |
NCT02452255 -
Fenofibrate and Propranolol in Burn Patients
|
Phase 2/Phase 3 | |
Completed |
NCT03183622 -
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-101 Clinical Trial
|
N/A | |
Completed |
NCT02427659 -
VR High Tech Pain Control Burn Wound Care
|
N/A | |
Not yet recruiting |
NCT00253279 -
Alterations in Protein Synthesis Rates of Burn Patients Measured Over Time Using PET Scans
|
Phase 1 | |
Completed |
NCT04516148 -
A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting
|
Phase 4 | |
Withdrawn |
NCT02029261 -
Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury
|
||
Completed |
NCT00993889 -
Virtual Reality Analgesia During Pediatric Physical Therapy
|
N/A | |
Completed |
NCT02394873 -
A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound
|
Phase 1 | |
Completed |
NCT00239668 -
Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors
|
||
Completed |
NCT04781348 -
Efficacy of Platelet Rich Plasma Injection Plus Fat Grafting as Compared to Fat Grafting Alone on Burn Scar by Using Vancouver Scar Scale
|
Phase 4 |