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Epidermal skin grafting: does it improve wound healing?

Conditions
chronic wound
skin cancer
10014982
Registration Number
NL-OMON54865
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
140
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

-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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary question:<br /><br>Does Epidermal Skin Grafting affect the wound healing of patients with acute<br /><br>and chronic wounds?<br /><br>The outcome measure of wound healing contains two variables, duration to total<br /><br>epithelialization and surface reduction per unit time. Both are measured using<br /><br>digital photography and independent assessment (total epithelialization) and<br /><br>digital photo analysis using the WHAT software (surface reduction).<br /><br>In the acute wound group without SSG, we expect faster wound healing by the ESG<br /><br>in the secondary healing donor site compared to the control group. In the acute<br /><br>and chronic wound group that is indicated for SSG, the ESG group is expected to<br /><br>display identical healing tendency as the SSG-receiving control group, but the<br /><br>benefit is in pain perception, more limited or absent appearance of the scar<br /><br>and an increased quality of life.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary questions:<br /><br>• What is the influence of ESG on the pain intensity of the donor and acceptor<br /><br>site during the treatment process? Pain is measured with NRS (Numeric Rating<br /><br>Scale) score<br /><br>• What is the quality of the scar of the secondary healing wound with ESG<br /><br>compared to the control group? The quality of the scar is measured with the<br /><br>validated POSAS method, whereby both the patient and the doctor give an opinion<br /><br>on, among other things, the redness, itching, swelling, lumpiness and pain of<br /><br>scars.<br /><br>• What is the influence on the patient's quality of life of both treatment<br /><br>routes? Quality of life is measured with the validated scales EQ5D (generic)<br /><br>and the Wound QoL (wound specific).</p><br>
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