Abstract
Purpose:
To examine the performance of a novel blood plasma-based bone putty for augmenting the treatment of open tibia fractures. The putty was manufactured from pooled blood plasma and contains a concentration of both plasma and platelet-derived regenerative factors. Based on clinical reports of the use of autologous platelet-rich plasma to treat injuries, we hypothesized that the putty would accelerate healing of fractures and surrounding soft tissues.
Methods:
Two-arm, randomized controlled study including 20 treatment patients and 10 controls. Follow-up examinations occurred at 14, 30, 60, 90, 180, and 365 days. The product was provided in a syringe containing 3 cc of putty in a double-pouched, sterile box. The putty was placed at the fracture site during open fracture reduction and mechanical stabilization.
Results:
Both treatment and control groups were well balanced with a mean age of 35. Seventy percent were Gustillo IIIA and IIIB injuries, 67% were active smokers, and 70% received external fixation.
No adverse events related to the use of the putty were noted.
The use of the putty significantly reduced infections at 90 days (p = 0.002), accelerated bone bridging at 90 and 180 days, and provided more rapid wound closure at 30 days.
In the subset of patients with IIIA/IIIB injuries, the putty group demonstrated more significantly reduced infections (p = 0.0007), with accelerated bone healing and wound closure approaching statistical significance. There were statistically fewer adverse events with the putty (42.1%) compared to controls (80.0%).
Conclusions:
The potential for using a concentration of natural plasma and platelet-derived regenerative factors to augment the healing of traumatic injuries makes this first-in-man study relevant and exciting. The putty performed as expected, promoting more rapid healing of both fractures and wounds. The dramatic reduction in infections was unanticipated and is likely related to antimicrobial peptides in plasma and platelets.
