Burns Clinical Trial
Official title:
A Prospective Multi-centre Randomised Study for Treatment of Burns With Dermis Graft or Split-thickness Skin Auto-graft.
Study Synopsis Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring. Design; the study is a prospective, controlled clinical multicenter trial. Study population; Atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover. Time plan; Enrollment will continue until atleast 20 patients have been included and completed the study.
Background: Donor site morbidity is a major concern such as wound healing disturbances, hypertrophic scarring and hypo-/hyperpigmentation. The dermal graft technique is an alternative to the standard split-thickness skin graft (STSG) technique to minimize donor site morbidity. Immediate cover of the donor site after harvest leaving a non-exposed wound is a big advantage. The aim of the study was to compare the functional and aesthetic outcome between two treatment methods (dermal graft with STSG). Methods: From February 2017 to December 2020, 21 patients received a dermis graft and a regular split-thickness skin graft in a prospective randomized study design. The recipient and the donor site were compared separately regarding healing time, scarring and patient subjective satisfaction. All sites (both donor and recipient) were analyzed histologically regarding remodeling and scar formation. ;
| 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 |
NCT00824681 -
Effect of Music Therapy on Families of Burn Patients
|
Phase 1 | |
| Terminated |
NCT00634166 -
Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
|
Phase 4 | |
| 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 |