Analysis of run-in and treatment data in a wound outcomes registry: clinical impact of topical platelet-rich plasma gel on healing trajectory

Abstract

Randomised controlled trials in chronic wounds typically exclude patients with comorbidities and confounding factors. Well-designed observational studies can provide complementary clinical evidence that randomised trials cannot address. This study determined if wound care registry outcomes could be an alternative data source and if the results would be robust and valid. Changes in wound area and depth were hypothesised to be different between run-in therapies and platelet-rich plasma (AutoloGel™, Cytomedix, Inc) treatment. From a treatment registry of 285 chronic wounds, 46 had run-in and post-treatment data. Seven chronic wound categories were identified. Mean wound age at study start was 52·4 days. General linear model repeated measures showed a credible and robust data set. Statistically significant differences for wound area and depth were observed between run-in and post-treatment period at multiple time points. Wound area and depth ≥50% reduction were analysed using Kaplan-Meier methods. During run-in, 15% of wound area improved compared to 28% post-treatment and 11% of wound depth improved during run-in compared to 39% post-treatment. Significant clinical outcomes indicated many previously non responsive wounds began actively healing in response to platelet-rich plasma therapy, indicating that registry data can be used as a complementary source of evidence.

Use of platelet‐rich plasma to facilitate wound healing

“…Dionyssiou et al supported the findings in accelerating the healing by PRP with the results of the histological study; according to which, the use of PRP as in our study contributed to the early appearance of granulation tissues, acceleration of epithelialisation, and stimulation of angiogenesis processes in wounds . PRP has proven itself in Kim et al and Carter et al studies showing the acceleration, proliferation, and migration of keratinocytes, and a significant reduction in the surface and depth of the wounds …”

“…There are a number of studies showing that the use of autologous PRP can improve the results of wound‐healing processes, as well as in cases of poorly healing wounds. Several controlled studies have given statistically significant evidence that the use of PRP leads to the acceleration of wound healing . There are three controlled studies on humans that reported of improvement of wound healing with regard to healing time, the quality of life, and reduction of pain .…”

Autologous platelet-rich plasma

“…It is thought that the application of aPRP gel directly to the wound site would increase the level of key growth factors, and thus speed the healing process. Studies and trials have compared aPRP gel to standard of care treatments, including debridement, topical antibiotic gel, and daily dressing changes [15][16][17]. A systematic review that included seven trials found inconclusive results for the role of aPRP in the complete healing of chronic skin ulcers (see Table 1) [18].…”

Retrospective Cohort Study Evaluating Clinical Outcomes in Lower Extremity Ulcers Treated with a Bi-layered Bioengineered Skin Substitute (BBSS) as Compared to Standard Therapy

“…This might be attributed to RCT designs that do not reflect the complex issues faced in clinical practice and are limited by the challenges of designing such studies given wound heterogeneity. Use of practice based evidence (PBE) and observational study data can provide important clinical insights that are generally missing from RCTs [7][8][9][10].…”