Histological Skin Changes of Different Peeling Agents in Surgically Subcutaneous Undermined Skin
Condition: Burn of Face, Head and/or Neck; Peeling
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): TCA 20% Peeling; Phenol/croton oil Peeling; TCA 40% Peeling
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): TCA peel at a concentration of 20% is applied on subcutaneous undermined skin samples for 2 to 4 minutes until even frosting and neutralized at the even frosting Point.; Phenol/croton oil is applied on subcutaneous undermined skin samples and occluded with silicone tape for 24 hours and not neutralized.; TCA peel at a concentration of 40% is applied on subcutaneous undermined skin samples for 2 to 4 minutes until even frosting and neutralized at the even frosting Point.
Intervention MeSH terms: Phenol; Croton Oil
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Peeling; Histological skin changes; Trichloroacetic acid peel; phenol/croton oil peel