Basement Membrane Regeneration for Wound Repair

NCT07551284 | Not Yet Recruiting

• 1 other identifier: SYSU-BM-REGEN-2025-01
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Wound Area Reduction Rate

  2 weeks after surgery

• Recurrence Rate

  6 months after surgery

• Scar Assessment

  Month 1, month 3, month 6

• Pain Score

  Postoperative day 7, 14, month 1, 3, 6

• Sweat Function Test

  Month 6

Other Outcomes (1)

• Incidence of Adverse Events

  From enrollment to 6 months after surgery

Study Arms (2)

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

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.

Interventions

Autologous Epidermal Basal Cell Suspension PROCEDURE

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.

Basement Membrane Regeneration Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04