Clinical trial NCT06439459: Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation
Official title: Quantitative Measurements of the Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Regeneration
Keywords: skin expansion
stromal vascular fraction
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, exploratory investigation aimed at exploring the efficacy of stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.

Detailed description: This study is a prospective, exploratory investigation aimed at exploring the efficacy of stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.

The trial aims to include patients experiencing dermal exhaustion during the process of skin soft tissue expansion. We will extract SVF components from autologous adipose tissue and injected intradermally into the expanded skin. The changes of dermis of expanded skin were recorded before the treatment (baseline), and at 4 weeks and 8 weeks follow-up timepoints after SVF transplantation. More specifically, skin surface area was measured using laser 3D scan; skin thickness and texture were detected by Doppler ultrasound, VISIA skin analyzer and CK skin analyzer; skin blood perfusion was analyzed using indocyanine green angiography.

Eligibility criteria: Inclusion Criteria:

* had undergone tissue expansion treatment;
* show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis (\<2mm) with no improvement after suspending expansion for 2 weeks;
* require further expansion to achieve the size for defect reconstruction.

Exclusion Criteria:

* Patients with serious underlying diseases such as cardiovascular or cerebrovascular disease, peripheral vascular disease, or impaired liver or kidney function;
* Patients with a long history of smoking and alcohol use who have not quit smoking or drinking;
* Patients allergic to iodine or iodine-containing preparations;
* Patients with psychiatric disorders, lack of insight, or those who cannot accurately express themselves or cooperate;
* Patients with contraindications for SVF transplantation, such as ulceration or infection of the expanded skin;
* Patients with severely loose skin or insufficient subcutaneous fat tissue;
* Patients who request to withdraw informed consent and exit the clinical trial.

Primary outcomes:
measure: Dermal thickness
timeFrame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation
Secondary outcomes:
measure: Skin surface area
timeFrame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation
Other outcomes:
measure: Skin texture (dermal rupture)
timeFrame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation
measure: Skin texture (elasticity)
timeFrame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation
measure: Skin perfusion
timeFrame: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
state: Huangpu
Study officials:
References: