chronic wound
Conditions
Interventions
ESG is the intervention in both groups. ESG is a one-time transplant of
epidermal cells from elsewhere on the patients body (the donor site) to the
wound (the acceptor site).
• In the acute wound gr
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -all patients who are sheduled to receive a skin transplant following skin cancer excision surgery; all patients suffering from a chronic ulcer who are sheduled to receive a SSG (split skin graft)
Exclusion criteria
Exclusion criteria: -the patient suffers from an oncologic ulcer in the wound area -the patient is known with alcohol or drug abuse -the patient cannot be informed correctly (e.g. because of language or mental problems) -the patient is unable to travel to the outpatient clinic for follow up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary question: Does Epidermal Skin Grafting affect the wound healing of patients with acute and chronic wounds? The outcome measure of wound healing contains two variables, duration to total epithelialization and surface reduction per unit time. Both are measured using digital photography and independent assessment (total epithelialization) and digital photo analysis using the WHAT software (surface reduction). In the acute wound group without SSG, we expect faster wound healing by the ESG in the secondary healing donor site compared to the control group. In the acute and chronic wound group that is indicated for SSG, the ESG group is expected to display identical healing tendency as the SSG-receiving control group, but the benefit is in pain perception, more limited or absent appearance of the scar and an increased quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary questions: • What is the influence of ESG on the pain intensity of the donor and acceptor site during the treatment process? Pain is measured with NRS (Numeric Rating Scale) score • What is the quality of the scar of the secondary healing wound with ESG compared to the control group? The quality of the scar is measured with the validated POSAS method, whereby both the patient and the doctor give an opinion on, among other things, the redness, itching, swelling, lumpiness and pain of scars. • What is the influence on the patient's quality of life of both treatment routes? Quality of life is measured with the validated scales EQ5D (generic) and the Wound QoL (wound specific). | — |
Countries
Netherlands
Outcome results
None listed