Full Thickness Skin Defects Clinical Trial
Official title:
A Phase 2, Intra-patient Randomised Controlled Multicentre International Study to Evaluate the Efficacy of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects
Verified date | February 2020 |
Source | Association of Dutch Burn Centres |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study the efficacy of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. The investigators expect this treatment to provide better outcome regarding scar quality.
Status | Completed |
Enrollment | 11 |
Est. completion date | September 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age =18 years (for Zurich: = 18 years) - Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm - = 50% TBSA full thickness skin defects at time of intervention - Informed consent by the patient and/or legal representatives. Exclusion Criteria: - Patients with infected wounds - Full thickness skin wounds located in face and/or genitals will not be included - Pregnant or breast feeding females - Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer) - Known allergy against porcine collagen or elastin - Patients that are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) - Previous enrolment of the patient into the current study |
Country | Name | City | State |
---|---|---|---|
Germany | Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie | Berlin | |
Netherlands | Red Cross Hospital | Beverwijk | Noord-Holland |
Switzerland | Children's Hospital Department of Surgery Kinderspital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Association of Dutch Burn Centres | Ernst Reichmann Tissue Biology Research Unit, Zürich, Seventh Framework Programme |
Germany, Netherlands, Switzerland,
Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Bühren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS) | Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS) | 3 months post-operative | |
Secondary | Graft take (Subjective assessment by experienced observer) | 5-7 days | ||
Secondary | Epithelialisation (Subjective assessment by experienced observer) | Subjective assessment by experienced observer | 5-7 days and 2-3 weeks post-operative | |
Secondary | Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire) | Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire | 12 months | |
Secondary | Scar quality (As determined with subjective scar assessment scale (POSAS) | As determined with subjective scar assessment scale (POSAS) | 3 and 12 months | |
Secondary | Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter) | As measured for scar colour and pigmentation using DSM II ColorMeter | 3 and 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Glyaderm + Split Thickness Skin Graft Versus Split Thickness Skin Graft Alone in Full Thickness Skin Defects
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