D03 C43 C49 C44 D04 C44.3
Conditions
Interventions
Group 1: Arm 1: Prospective observational study in patients undergoing surgical excision of precancerous or malignant skin lesions with subsequent secondary wound healing. Following tumour excision, t
Sponsors
MVZ Hautzentrum am Holzmarkt
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male and female patients aged at least 18 years; ability to provide informed consent and written informed consent for study participation; willingness and ability to attend regular outpatient follow-up visits; diagnosis of a cutaneous tumor requiring surgical excision (basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, or malignant melanoma, including their precancerous lesions, as well as other malignant tumors not explicitly listed above) with planned complete surgical removal (R0 resection), irrespective of anatomical location; iatrogenic skin defect resulting from tumor excision, irrespective of size, depth, or anatomical location; resulting wound area considered by the treating physician to be unsuitable for primary wound closure or plastic surgical reconstruction (e.g. due to anatomical location, wound tension, comorbidities, contraindications to reconstructive procedures, or planned secondary wound healing); the decision for secondary wound healing may additionally be based on the explicit preference of the patient, provided that no medical contraindication exists in the opinion of the treating physician.
Exclusion criteria
Exclusion criteria: Vulnerable individuals (e.g. persons with impaired capacity to provide informed consent or without appropriate legal representation where required); previous radiotherapy in the wound region; known allergy to polylactide or components of the wound matrix; systemic immunosuppressive therapy within the previous 6 months, with the exception of maintenance corticosteroid therapy (less than 15 mg prednisone or equivalent per day) and immunomodulatory therapy for conditions such as psoriasis; active infection in the surgical area that does not permit the planned intervention; decompensated underlying disease associated with insufficient cardiovascular stability; participation in other clinical studies whose interventions could influence the course of wound healing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving complete wound epithelialization 12 weeks after the first application of SUPRA SDRM®. Definition: Complete wound epithelialization is defined as complete wound closure with an intact epidermis and no moist or exudative areas. Assessment time points: Weeks 1, 2, 3, 4, 6, 8, 12, and 16 following the first application of SUPRA SDRM®. Primary analysis time point: Week 12. Assessment method: Physician assessment and confirmation by standardized photographic documentation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to 50% wound closure (or 50% reduction in wound area) Definition: Time from the first application of SUPRA SDRM® to achievement of at least a 50% reduction in wound area compared with baseline. Assessment time points: Weeks 1, 2, 3, 4, 6, 8, 12, and 16. Assessment method: Clinical wound assessment and standardized photographic documentation. Infection rate, complication rate, and need for antibiotic therapy Definition: Occurrence of clinical signs of infection, wound-related complications, and administration of antibiotic therapy during the observation period. Assessment time points: Continuously throughout the study period and at each follow-up visit (Weeks 1, 2, 3, 4, 6, 8, 12, and 16). Assessment method: Clinical examination and documentation of complications (e.g., wound infection, bleeding, hematoma, seroma, wound dehiscence, hypergranulation, delayed wound healing) as well as documentation of any required antibiotic treatment. Pain intensity Definition: Patient-reported wound-related pain. Assessment time points: Baseline (prior to surgery) and Weeks 1, 2, 3, 4, 6, 8, 12, and 16. Assessment method: Numeric Rating Scale (NRS; 0–10 points). Scar quality Definition: Scar quality following wound healing. Assessment time points: Weeks 12 and 16. Assessment method: Patient and Observer Scar Assessment Scale (POSAS), assessed by a study physician who was not involved in the surgical procedure. Quality of life Definition: Health-related quality of life. Assessment time points: Baseline (prior to surgery), Week 6, Week 12, and Week 16. Assessment method: Skin Cancer Index (SCI; Skin Cancer Index questionnaire). | — |
Countries
Germany
Contacts
Public ContactKatrin Kofler
MVZ Hautzentrum am Holzmarkt
Outcome results
None listed