The Combination Therapy of Nanofat Grafting and PRP Compared With Microfat Grafting and PRP Synergy in Treating Striae Distensae

Sponsor
First Affiliated Hospital of Jinan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03807986
Collaborator
Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd. (Other)
12
1
2
23
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Nanofat grafting
  • Procedure: Microfat grafting
  • Procedure: Platelet-rich plasma (PRP) Injection
N/A

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
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Feb 1, 2019
Anticipated Primary Completion Date :
May 1, 2019
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nanofat grafting and PRP injection

Striae diatensae will be treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.

Procedure: Nanofat grafting
Nanofat grafting will be applied once every three months for 2 times.

Procedure: Platelet-rich plasma (PRP) Injection
PRP Injection will be applied once a month for 6 times.

Experimental: Microfat grafting and PRP injection

Striae diatensae will be treated by microfat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.

Procedure: Microfat grafting
Microfat grafting will be applied once every three months for 2 times.

Procedure: Platelet-rich plasma (PRP) Injection
PRP Injection will be applied once a month for 6 times.

Outcome Measures

Primary Outcome Measures

  1. Immunohistochemical analysis [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 Outcome Measures

  1. Ultrasound [Change from baseline dermal thickness at 3,6,9,12,15 months of the treatments.]

    The striae distensae will be assessed by ultrasound in order to observe the change of dermal thickness of striae after the application of nanofat or microfat grafting with PRP injection. if the treatments worked, the dermal thickness will be increased.

  2. Ultrasound [Change from baseline width of striae at 3,6,9,12,15 months of the treatments.]

    The striae distensae will be assessed by ultrasound in order to observe the change of width of striae after the application of nanofat or microfat grafting with PRP injection. Smaller the width better the results.

Other Outcome Measures

  1. Satisfaction assessments of participants: questionnaire [At 15th month.]

    The participants will fill in a questionnaire about the efficacy of the treatments. Participants will choose one of the following answers 'satisfied, unchanged, not satisfied' as feedback.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Jinan University Guangzhou Guangdong China 500011

Sponsors and Collaborators

  • First Affiliated Hospital of Jinan University
  • Science and Technology Program of Guangzhou,Guangzhou Sipintang Biological technology Co., Ltd.

Investigators

  • Principal Investigator: Li Ling Xiao, MD, First Affiliated Hospital of Jinan University

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Li-Ling Xiao, Associate Chief of Department of Plastic Surgery, First Affiliated Hospital of Jinan University
ClinicalTrials.gov Identifier:
NCT03807986
Other Study ID Numbers:
  • Xiao FirstJinanU
First Posted:
Jan 17, 2019
Last Update Posted:
Jan 17, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Li-Ling Xiao, Associate Chief of Department of Plastic Surgery, First Affiliated Hospital of Jinan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2019