The Combination Therapy of Nanofat Grafting and Platelet-Rich Plasma Injection Compared With Microfat Grafting and Platelet-Rich Plasma Injection Synergy in Treating Striae Distensae
Overview
- Phase
- Not Applicable
- Sponsor
- First Affiliated Hospital of Jinan University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Immunohistochemical analysis
Overview
Brief Summary
Striae distensae is caused by the fracture and damage of the elastic fibers and collagen fibers, which is still a difficulty to overcome. Based on the studies demonstrated that platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat are effective in treating atrophic scar. So in this clinical trial, the investigators are going to treat striae distensae by using two combination therapies. One is nanofat grafting and PRP injection synergy, and the other one is treated by microfat grafting with PRP injection.
Detailed Description
The participants were randomly assigned into two groups. Group A is treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. Group B will be treated by microfat grafting onceevery three months for 2 times combined with PRP injection once a month for 6 times. The participants were asked to come back 1、3、6、9 months after treatment for further follow-up.Before and after the treatment, the striae distensae will be assessed subjectively by satisfaction assessment, and objectively by ultrasound and immunohistochemical analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The striae distensae
- •Age ≤ 35 years old
Exclusion Criteria
- •Skin allergy
- •Cicatricial diathesis
- •Skin inflammation or wound
- •Platelet dysfunction syndrome
- •Take anticoagulant drugs
- •Acute or chronic infection
- •Chronic liver disease
- •Active vitiligo, psoriasis, systemic lupus erythematosus
Outcomes
Primary Outcomes
Immunohistochemical analysis
Time Frame: Change from baseline at 15 months.
The tissue extracted will be taken for immunohistochemical analysis to observe the amount of elastic fiber and collagen fiber,etc. More collagen fiber generated better outcome of the treatments.
Secondary Outcomes
- Ultrasound(Change from baseline width of striae at 3,6,9,12,15 months of the treatments.)
Investigators
Li-Ling Xiao
Associate Chief of Department of Plastic Surgery
First Affiliated Hospital of Jinan University