Basement Membrane Regeneration for Wound Repair

ConditionWound Healing

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Autologous Epidermal Basal Cell Suspension
Procedure/Surgery
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.

Treatment groups

1,000 Participants

are divided into 2 treatment groups

Group A: Basement Membrane Regeneration Group1 intervention

Group B: Conventional Surgery Group0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

From surgery to complete healing, assessed up to 6 months

Secondary outcomes

Wound Area Reduction Rate

Percentage reduction in wound area calculated as (baseline area - current area) / baseline area × 100%.

Time frame

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.

Time frame

6 months after surgery

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.

Time frame

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.

Time frame

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

Other outcomes

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.

Time frame

From enrollment to 6 months after surgery

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

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