Burn Injuries Clinical Trial
Burn injury with full-thickness skin damage that encompass large body surface areas can
induce local and systemic perturbations that are costly in terms of human suffering as well
as in strains on the health care system. Characterization of new major molecular biomarkers
involved in this process creates significant diagnostic and therapeutic challenges.
Hypoxia-inducible factor-1 α (HIF-1 α) is a ubiquitously expressed heterodimeric
transcription factor comprising an α and a β subunit. It was shown that under normoxic
conditions, the HIF-1α subunit is ubiquitinated and degraded, whereas under hypoxic
conditions, HIF-1α accumulates, dimerizes with HIF-1β, and activates the transcription of a
spectrum of target genes encoding multiple angiogenic growth factors and cytokines of
potential importance in wound healing. Seven isoforms of HIF-1α issued from alternative
splicing have been identified.
The importance of HIF-1α in wound healing in animal models has been suggested by several
studies. Indeed, diminished HIF-1 levels and activity have been documented in conditions of
impaired wound healing. The literature review shows a marked reduction of HIF-1α levels in
mice in case of burn wound skin that in the case of excisional cutaneous wound. Other
studies have shown that the expression of HIF-1α was correlated with the extent and depth of
the burns.
This study aims to improve the knowledge on the pathophysiological factors involved in the
field of wound healing. The assumptions are based on results of studies done on mice, and
this work aims to document these findings in humans.
Objective
The main objective of the study is to compare the variations of expression of HIF-1α
measured in blood and skin tissue samples in three groups:
- Subjects with major burn wounds involving more than 20% of the total body surface area;
- Subjects with burn wounds smaller than 5% of total body surface area;
- Subjects with a skin wound after a surgical procedure requiring a skin resection.
Secondary objectives are to compare the expression levels of HIF-1α locally at the burn site
to those observed in blood, to evaluate the expression of growth factors produced by HIF-1α
target genes (VEGF and EPO) or playing a central role in the healing process (TGF-β1), and
to assess the correlation between the expression of HIF-1α and the kinetics of wound healing
of the subject rated by evaluation of time of donor sites complete epithelialization.
Material and Methods
We propose to create three groups:
- 15 patients with extensive third degree burns involving more than 20% of the total body
surface area;
- 15 patients with less extensive third degree burns, involving less than 5% of body
surface area;
- 15 patients with post-surgical wounds with skin resection. Skin and tissue specimens
will be collected three times: day 0, 7 and 14 from burned patients (with more than 20%
of the total body surface area and less than 5% of body surface area). Samples of skin
tissue will be collected within the skin resection from patients with post-surgical
wounds at day 0, blood samples will be collected at day 0 and 14.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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