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Not yet recruiting NCT07551284

Basement Membrane Regeneration for Wound Repair

— Observational Wound Healing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous Epidermal Basal Cell Suspension.
Who it may be relevant to
Registry conditions: Wound Healing. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multicenter, Real-World Observational Study of Autologous Basement Membrane Regeneration Technology (Epidermal Basal Cell Suspension Using Cell Sorting System) for Wound Repair in Patients Undergoing Skin Grafting, Flap Surgery, or Primary Suture

Overview

This study is a prospective, multicenter, real-world observational study. It aims to evaluate the effectiveness and safety of autologous basement membrane regeneration technology (epidermal basal cell suspension prepared using a cell sorting system) for wound repair in patients undergoing skin grafting, flap surgery, or primary suture. A total of 500 patients receiving the cell suspension therapy combined with standard surgical procedures will be enrolled from multiple hospitals across China. Their outcomes will be compared with 500 matched patients receiving standard surgical procedures alone (e.g., skin grafting, flap surgery, or suture without cell suspension). The primary outcomes include complete wound healing rate at 4 weeks (for grafted wounds) and time to complete wound closure (for sutured or flap-repaired wounds). Secondary outcomes include wound area reduction rate, recurrence rate, scar assessment (Vancouver Scar Scale), pain score (ASA), sweat function test, basement membrane integrity (histopathology with collagen IV and VII staining if clinically indicated), and safety. Patients will be followed for up to 6 months.

Interventions

  • Procedure Autologous Epidermal Basal Cell Suspension
    A suspension of basal cells enriched from the patient's own split-thickness skin graft using a cell sorting system. The suspension contains epidermal basal cells and basement membrane components. It is applied to the wound bed or injected along suture lines to promote in situ basement membrane regeneration, enhance wound healing, and reduce scar formation.

Primary outcome measures

  • Complete Wound Healing Rate at 4 Weeks (for grafted wounds) [Time frame: 4 weeks after surgery]
  • Time to Complete Wound Healing (for sutured or flap-repaired wounds) [Time frame: From surgery to complete healing, assessed up to 6 months]
Secondary outcome measures (5)
  • Wound Area Reduction Rate [Time frame: 2 weeks after surgery]
  • Recurrence Rate [Time frame: 6 months after surgery]
  • Scar Assessment [Time frame: Month 1, month 3, month 6]
  • Pain Score [Time frame: Postoperative day 7, 14, month 1, 3, 6]
  • Sweat Function Test [Time frame: Month 6]

Eligibility criteria

Inclusion criteria

  • Patients with wounds requiring surgical repair (skin grafting, flap surgery, or primary suture), including but not limited to: burn wounds, traumatic wounds, post-surgical excision defects (e.g., scars, pigmentation disorders, skin tumors), and chronic wounds (diabetic ulcers, venous ulcers, pressure injuries, radiation ulcers, neuropathic ulcers, burn residual wounds, etc.).
  • Age (No age restriction). For minors under 18 years, informed consent must be provided by a parent or legal guardian.
  • Stable vital signs and able to tolerate surgery as confirmed by routine examinations.
  • Understand and willing to participate and able to provide signed informed consent.

Exclusion criteria

  • Severe uncontrolled systemic disease or acute systemic infection, rapidly progressive or advanced disease, or severe organ dysfunction (heart, lung, brain, etc.).
  • Psychiatric disorder.
  • Presence of diseases (e.g., malignant tumor, autoimmune disease) or use of medications (e.g., high-dose corticosteroids: ≥40 mg prednisone or equivalent per day for ≥2 weeks) that may affect wound healing.
  • HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) < 1000 cells/mm³ during screening.
  • Pregnancy or breastfeeding.
  • Active infection or necrosis of the wound (unless controlled after debridement).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07551284 · SYSU-BM-REGEN-2025-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗