Basement Membrane Regeneration for Wound Repair

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Healing
• Intervention / Treatment: Procedure: Autologous Epidermal Basal Cell Suspension

• Study Type: Observational
• Enrollment (Estimated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from patients with wounds requiring surgical repair (skin grafting, flap surgery, or primary suture) at the burn units, plastic surgery departments, or wound repair departments of 10 participating tertiary hospitals across China, with Sun Yat-sen University First Affiliated Hospital serving as the lead center.

Eligible participants are those requiring surgical wound repair who meet the inclusion criteria. Patients in the experimental group will receive autologous epidermal basal cell suspension combined with standard surgical procedures. Patients in the control group will receive standard surgical procedures alone (skin grafting, flap surgery, or primary suture without cell suspension). Group assignment is based on clinical practice and patient preference, not randomization.

The study covers diverse wound types, including acute wounds (burns, trauma, post-excision defects) and chronic wounds (diabetic ulcers, venous ulcers, pressure injuries, et

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Basement Membrane Regeneration Group; Patients receiving autologous epidermal basal cell suspension (prepared using a cell sorting system from a split-thickness skin graft) combined with standard surgical procedures. The cell suspension is sprayed onto the wound bed before skin grafting or injected continuously at points along both sides of the suture line after flap surgery or tension-reducing suture to promote in situ basement membrane regeneration.	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.
Conventional Surgery Group; Patients receiving standard surgical procedures alone (skin grafting, flap surgery, or primary suture) without autologous epidermal basal cell suspension. Wound debridement, dressing changes, and postoperative care are identical to the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Wound Healing Rate at 4 Weeks (for grafted wounds)	Proportion of skin graft recipient sites achieving complete epithelialization without drainage at 4 weeks post-surgery.	4 weeks after surgery
Time to Complete Wound Healing (for sutured or flap-repaired wounds)	Number of days from surgery to complete wound closure (100% re-epithelialization or suture removal without dehiscence) for primarily sutured wounds or flap-repaired wounds.	From surgery to complete healing, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Area Reduction Rate	Percentage reduction in wound area calculated as (baseline area - current area) / baseline area × 100%.	2 weeks after surgery
Recurrence Rate	Proportion of participants experiencing wound recurrence (re-ulceration at the same site or scar hyperplasia affecting function) within 6 months after complete healing.	6 months after surgery
Sweat Function Test	Assessment of sweat gland function recovery in the healed wound area using standardized sweat testing.	Month 6
Scar Assessment	Scar quality is evaluated using the Vancouver Scar Scale (VSS), which assesses four parameters: vascularity, pigmentation, pliability, and height. Scale specifications: The VSS is a 0-13 scale (0 = normal skin, 13 = worst possible scar), where higher scores indicate worse scar outcome.	Month 1, month 3, month 6
Pain Score	The ASA is a 0-10 scale, where higher scores indicate worse pain (0 = no pain, 10 = worst possible pain). Note: Please confirm if this interpretation aligns with your study's use of ASA.	Postoperative day 7, 14, month 1, 3, 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Proportion of participants experiencing local adverse reactions (infection, hematoma, seroma, graft necrosis, delayed healing, donor site complications, hypertrophic scarring) or systemic adverse reactions (fever, allergy). Rate of re-operation due to complications will also be recorded.	From enrollment to 6 months after surgery

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SYSU-BM-REGEN-2025-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No