Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01062191
Study type Interventional
Source ULURU
Contact
Status Terminated
Phase N/A
Start date May 2007
Completion date October 2008

See also
  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