NCT03935594

Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars

Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars; A Randomized Controlled Double-Blinded Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Hypertrophic burn scars are experienced by more than 70% of burn victims. They are a major source of decreased quality of life in burn patients due to pain, decreased range of motion, and poor cosmetic appearance. Current treatment strategies (including fat grafting and laser resurfacing) are either highly invasive, prohibitively costly, or painful. Autologous Platelet Rich Plasma (PRP) does not require anesthesia, and is an inexpensive, safe, fast, and less painful alternative that has been recognized for its role in reducing scars associated with acne, among other things. While PRP has not been studied specifically in burn scars, there is sufficient theoretical and practical evidence that it will improve the appearance and feel of these debilitating scars, representing a large potential benefit for these patients with minimal associated risk.

Detailed description

Severe burn injury is associated with hypertrophic scarring, which occurs in up to 70% of burn patients (Finnerty et al., 2016). Burn scars are particularly troublesome because they cause debilitating neuropathic pain and itch, joint contractures and stiffness that limit range of motion, inability to sweat, and physical disfigurement of cosmetically sensitive areas such as the hands and face. Autologous platelet-rich plasma (PRP) is plasma with a higher concentration of platelets, and is prepared by drawing up a small amount of a patient's blood, centrifuging it, and collecting the platelet-rich layer. Many automated machines exist for doing this process. Platelets contain a multitude of growth factors and other small molecules that have been shown to promote wound healing and tissue regeneration in a variety of contexts. PRP, which is rich in these healing growth factors, has been studied extensively and has proved to be both a safe and effective treatment modality for a wide range of applications, including acne scars and hair loss (Elghblawi et al., 2018). It has been shown to be a safe and effective treatment for some types of surgical and traumatic scars, and has been safely applied to acute burn wounds where it has been shown to improve healing and subsequent scarring (Venter et al., 2016). Despite these known uses of PRP, its role in reducing the extent and severity of mature hypertrophic burn scars after they have already healed is notably lacking in the literature. The purpose of this study is to assess whether intradermally-injected autologous platelet-rich plasma improves the size, texture, color, elasticity, contour, and neuropathic pain associated with mature burn scars. Specific Aims: 1. Compare the effectiveness of intradermally-injected autologous platelet-rich plasma versus normal saline (NS) to improve burn scars, as measured by both clinician-reported (Vancouver scar scale; VSS) and patient-reported measures (Patient and Observer Scar Assessment Scale; POSAS). 2. Compare the effectiveness of intradermally-injected autologous platelet-rich plasma versus normal saline as a control to improve neuropathic pain associated with burn scars. 3. Understand the mechanism of action of PRP in improving burn scars via histological analysis of collagen content in the burn scar tissue biopsy specimens.

Conditions

• Hypertrophic Scar

Interventions

Type	Name	Description
BIOLOGICAL	PRP Injection	1mL platelet rich plasma will be injected into each 1cm x 1cm area of scar tissue of the experimental half of the scar.
DRUG	Saline Injection	1mL NS will be injected into each 1cm x 1cm area of scar tissue of the control half of the scar.

Timeline

• Start date: 2020-09-18
• Primary completion: 2021-05-24
• Completion: 2022-10-19
• First posted: 2019-05-02
• Last updated: 2023-01-09
• Results posted: 2023-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study