Clinical Trials Logo
  1. Home
  2. Skin Wound
  3. NCT03005054

StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Burns Clinical Trial

Official title:
Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Clinical Trial Summary

About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body. This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss. Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.

Clinical Trial Description

The objective of this range-finding study was to assess the safety, tolerability, and efficacy of single or repeated application of StrataGraft skin tissue in full-thickness complex skin defects resulting from acute traumatic skin loss (eg, thermal burns or degloving injuries) requiring surgical excision and autografting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03005054
Study type Interventional
Source Mallinckrodt
Contact
Status Terminated
Phase Phase 2
Start date April 24, 2017
Completion date March 26, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Completed NCT05276869 - Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Not yet recruiting NCT06076031 - Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing N/A
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Recruiting NCT04090424 - Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03159182 - Study of Silicone Material Inserts To Treat Burn Scars N/A
Recruiting NCT02904941 - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns N/A
Completed NCT02681757 - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Completed NCT01214811 - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing Phase 3
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Terminated NCT00634166 - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group Phase 4
Terminated NCT00824681 - Effect of Music Therapy on Families of Burn Patients Phase 1
Terminated NCT00464386 - Continuous Glucose Monitoring (POC) in the ICU N/A
Withdrawn NCT00216983 - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding N/A