Hypertrophic Scar Clinical Trial
Official title:
Use of Autologous Platelet-Rich Plasma to Treat Hypertrophic Burn Scars; A Randomized Controlled Double-Blinded Trial
Verified date | December 2022 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | October 19, 2022 |
Est. primary completion date | May 24, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Hypertrophic burn scar present on trunk or abdomen Exclusion Criteria: - Initial burn injury less than 1 year old - History of chemical or electrical burn - Genetic or acquired conditions that severely affect systemic wound healing or collagen formation (vasculitis, diabetes, Ehlers-Danlos syndrome, radiation therapy to the scar site or use of immunosuppressive medications within the last year, active cancer) |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Asif M, Kanodia S, Singh K. Combined autologous platelet-rich plasma with microneedling verses microneedling with distilled water in the treatment of atrophic acne scars: a concurrent split-face study. J Cosmet Dermatol. 2016 Dec;15(4):434-443. doi: 10.1111/jocd.12207. Epub 2016 Jan 8. — View Citation
Cervelli V, Nicoli F, Spallone D, Verardi S, Sorge R, Nicoli M, Balzani A. Treatment of traumatic scars using fat grafts mixed with platelet-rich plasma, and resurfacing of skin with the 1540 nm nonablative laser. Clin Exp Dermatol. 2012 Jan;37(1):55-61. doi: 10.1111/j.1365-2230.2011.04199.x. — View Citation
Klosova H, Stetinsky J, Bryjova I, Hledik S, Klein L. Objective evaluation of the effect of autologous platelet concentrate on post-operative scarring in deep burns. Burns. 2013 Sep;39(6):1263-76. doi: 10.1016/j.burns.2013.01.020. Epub 2013 Mar 5. — View Citation
Prochazka V, Klosova H, Stetinsky J, Gumulec J, Vitkova K, Salounova D, Dvorackova J, Bielnikova H, Klement P, Levakova V, Ocelka T, Pavliska L, Kovanic P, Klement GL. Addition of platelet concentrate to dermo-epidermal skin graft in deep burn trauma reduces scarring and need for revision surgeries. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2014 Jun;158(2):242-58. doi: 10.5507/bp.2013.070. Epub 2013 Sep 27. — View Citation
Ruiz A, Cuestas D, Garcia P, Quintero J, Forero Y, Galvis I, Velasquez O. Early intervention in scar management and cutaneous burns with autologous platelet-rich plasma. J Cosmet Dermatol. 2018 Dec;17(6):1194-1199. doi: 10.1111/jocd.12554. Epub 2018 Apr 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Scar Assessment: POSAS at 2 Months | Scar will be measured by Patient and Observer Scar Assessment Scale ( POSAS ) on both sides of the scar. POSAS score is an assessment of scar severity. The range is 6-60. 6=normal skin and 60= severely scarred skin. | 2 months | |
Primary | Scar Assessment: VSS at 2 Months | Scar will be measured by Vancouver Scar Scale (VSS) on both control half and experimental half. VSS score is an assessment of scar severity. Four characteristics of the scar are assessed. These are: vascularity, height, pliability, and pigmentation. Each characteristic is given a score, which are added together to give an overall score between 0 and 13. 0= normal; 13=severely scarred. | 2 months |
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