The safety of an autologous whole blood clot product applied to full thickness dermal wounds in a porcine model for up to 18 days
Authors Serena TE, Kushnir I, Kushnir A, Yaakov RA, Eckert KA
Received 5 October 2018
Accepted for publication 30 March 2019
Published 19 June 2019 Volume 2019:6 Pages 39—49
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 3
Editor who approved publication: Professor Marco Romanelli
Thomas E Serena,1 Igal Kushnir,2 Alon Kushnir,2 Raphael A Yaakov,1 Kristen A Eckert3
1Clinical Research, Serena Group, Inc, Cambridge, MA, USA; 2RedDress Ltd., Pardes-Hanna, Israel; 3Strategic Solutions, Inc, Cody, WY, USA
Introduction: Blood has become a major source for wound care products due to its primary role in wound healing. The blood clot provides a fibrin scaffold that serves as a protective, provisional extracellular matrix. The clot dries out and becomes a protective scab, under which a moist wound environment can be maintained. In this study, the safety of an autologous whole blood clot product was evaluated in porcine models.
Methods: A total of 24 full thickness dermal wounds were analyzed (6 wounds on each of the 4 porcine models). Eighteen wounds received the whole blood clot product and 6 were treated with saline soaked gauze for 18 days. Reapplications occurred on days 6 and 12. Histological evaluations were carried out to detect the presence of kaolin. Percentage area reduction and adverse events related to the whole blood clot product were assessed.
Results: Microscopic evaluation revealed that the whole blood clot product was associated with partial to complete wound reepithelialization, whereas minimal reepithelialization was present with the control. The mean reepithelialization score for the control wounds was 1.0, or 2.3 times less than the mean score for the intervention group. By day 18, the mean reduction in wound area was 41% (SD: 3.8) for the control wounds versus 66% (SD: 6.4) for the wounds treated with the whole blood clot product (P<0.0001).
Keywords: blood clot, therapeutics, safety, swine, wounds
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