Objective: The Rigenera system is a new standardised micrograft preparation system. It works by means of automated mechanical disaggregation of small tissue samples, extracting only the smallest cells (<50µm). The aim of this study was to retrospectively evaluate patients affected by chronic ulcers and who were treated with the micrograft preparation method.
Method: Chronic ulcers have been included regardless of the cause. The specimen was collected with a 3mm diameter biopsy punch and immediately dissociated by means of the Rigenera System. The obtained suspension was placed on a scaffold of equine collagen.
Results: We included 15 patients (four males, 11 females) with a mean age of 72.2±8.41 (mean±standard deviation) years. In seven patients the ulcers were related to the complications of diabetes, post-traumatic in a further three diabetic patients, vasculitis in one patient, and four patients had venous leg ulcers (VLUs). The median main diameter was 5.0cm and the median estimated area was 43.96cm2. The ulcers were present from a mean of 4.50±2.30 months before inclusion in this study. At the second week the wounds were reduced by 37.33%±19.35%, at the week eight, nine patients (60.0%) were healed, and at week 16, 13 (86.7%) were healed. The quality of scars was good and did not deteriorate at the six month follow-up.
Conclusion: The simplicity of the approach, the minimal invasiveness of the specimen collection, and the good quality of scarring of healed wounds, confirmed in the follow-up, makes this micrograft preparation method a useful tool to use on large or complex wounds.
Keywords: Rigenera; regenerative medicine; skin ulcer; stem cells; transplants; wound healing.