Wounds Clinical Trial
Official title:
A Prospective, Randomized Controlled, Double Blinded, Clinical Multicentre Trial of the Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure
This study is a prospective, randomized controlled, double blinded, study in a multi centre
setting. Three burn centres will include 60 patients in total.
If suited for the study (= two equal donor sites) and after informed consent, patients will
be observed starting the day of skin prelevation.
A coded file will be made for each patient and these files should contain the localization
of both donor sites, their depth as determined by the setting of the dermatome and the
treatment. Treatment for both donor sites will always be equal.
The date of wound healing of each donor site, which may only differ by a maximum of five
days, will be noted. Digital photographs of the healed donor sites will be taken and the
scars will be evaluated by the local researchers using the Adapted Vancouver Scar Scale
prior to the start of hydration.
From that moment on one donor site will be treated with Aruba Aloe formula F-BC-096 while
one of the control products will be applied to the second site. Per group of five patients
per centre a different control product will be applied to the second donor site. The tubes
containing these products will be colour and numerical coded. Nor the treating personnel,
nor the patients will be informed which colour tubes contain the control products and which
contain the Aruba Aloe formula F-BC-096. If it is necessary to apply pressure garments for
one donor site, the garments will be applied for both sites.
Follow-Ups will be performed on one, three and six months after wound closure. Objective
methods will be used during these follow-ups to evaluate elasticity and colour of the scar,
this by using the Dermalab, the Cutometer®, the Derma Spectrometer and the Mexameter®. The
evaporation, permeability and hydration of the scar will be measured by using the Tewameter®
and the Corneometer®. The Reviscometer® will measure the direction of collagen and elastin.
The Adapted Vancouver Scar Scale will be used as a subjective method. Also different scales
for evaluation of donor site pain, patient satisfaction, product comfort, itching etc. have
to be completed by the patient.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02865902 -
Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness
|
N/A | |
| Completed |
NCT01227759 -
Tyrosur® Gel-Investigation on Wound Healing Efficacy
|
Phase 2 | |
| Terminated |
NCT01191567 -
Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
|
N/A | |
| Recruiting |
NCT00737425 -
Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
|
Phase 4 | |
| Completed |
NCT00746109 -
Study of Wound Packing After Superficial Skin Abscess Drainage
|
Phase 4 | |
| Terminated |
NCT00762138 -
The AutoloGel™ Post-Market Surveillance (TAPS) Program
|
N/A | |
| Withdrawn |
NCT00234559 -
Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis
|
N/A | |
| Not yet recruiting |
NCT03872544 -
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
| Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
| Recruiting |
NCT05588583 -
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
|
N/A | |
| Completed |
NCT02591537 -
OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University
|
N/A | |
| Completed |
NCT00792688 -
Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
|
Phase 2 | |
| Recruiting |
NCT05608317 -
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
|
N/A | |
| Recruiting |
NCT02195063 -
Survey Study for Pain Management, Wound Care, Scar Care or UDT
|
Phase 4 | |
| Completed |
NCT01319149 -
A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes
|
N/A | |
| Completed |
NCT00153452 -
Workplace Productivity of Persons Who Use Controlling Behavior With Intimate Partners
|
N/A | |
| Completed |
NCT06083740 -
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
|
||
| Not yet recruiting |
NCT02672280 -
Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT02314416 -
Stem Cells In Wound Healing With Collagen Matrix as a Carrier
|
Phase 4 | |
| Recruiting |
NCT01454167 -
Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications
|
N/A |