Burn of Face, Head and/or Neck Clinical Trial
Official title:
Histological Evaluation of Peeling Induced Skin Changes of Different Peeling Agents in Surgically Subcutaneous Undermined Skin Flaps in Facelift Patients
The purpose of this study is to examine the histological skin changes induced by different peeling agents (Trichloroacetic acid 25% and 40% and phenol/croton oil) in subcutaneous undermined facial skin flaps.
Written informed consent has to be obtained from 9 random female Caucasian patients aged
between 40 and 80 years who will receive a Peeling assisted volume enhancing (PAVE) facelift
procedure in Ocean Clinic, Marbella Spain, to take part in the histologic case control study
with a within-subjects design.
After completing the facelift, the subcutaneous undermined abundant pre-auricular skin of
both sides which is to be resected as consequence of the lift anyhow of each study patient
is not resected and split completely in half to yield four samples of the same size, two on
each side, without contacting each other in order to prevent any interaction between the
peeling agents (n=9 samples per treatment). One sample serves as the control, while the
other three samples are each treated with different peeling agents by the same surgeon:
Trichloroacetic acid (TCA) peel at concentrations of 20% and 40% and a phenol/croton oil
peel. The TCA samples are peeled immediately for 2 to 4 minutes until even frosting and
neutralized at the even frosting point. The phenol/croton oil peeled samples are occluded
with silicone tape for 24 hours and not neutralized. After 24 hours during the routine
in-hospital stay of the patient, the skin samples are resected, the preauricular wound is
closed, and all samples are placed in 10 % neutral buffered formalin. The samples are
immediately processed, trimmed, embedded, sectioned and stained with haematoxylin and eosin
(H&E) by the same researcher. Histological evaluation which will take place in Tuebingen is
carried out using a microscope, and pictures are captured at 10x, 25x and 100x magnification
using a digital camera. Two trained histological examiners blinded to the study design
independently perform histological evaluations. The depth of necrosis in µm is determined by
analysing the tissue damage in relation to histological skin layers. All slices are
evaluated using light microscopy to assess the mean depth of necrosis in three samples at
three different sites for each specimen. The vertical height in µm between the cutaneous
basal membrane and the deepest penetration of tissue damage is measured as well as the total
thickness of the epidermis and dermis. Based on the histomorphological changes, actual
peeling depth is determined and classified analogously to the current classification of
burns: superficial, superficial-partial, deep-partial and full thickness.
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