Oasis Donor Site Wounds Post-Market Study

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom. Oasis ECM is commercially available for the treatment of partial and full-thickness skin wounds, including chronic wounds, wounds from trauma, and wounds that occur during surgery, such as donor site wounds. The ability of the Oasis ECM to promote the healing of donor site wounds will be evaluated in this study. About 40 patients (20 in each arm) over 16 years old will be involved in this study at one center in the United Kingdom.

Official Title
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Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds

Conditions
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Surgical Wound, Wound, Wounds and Injuries, Wound Heal

Intervention / Treatment
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* Device: Oasis ECM
* Other: standard wound care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material. Has at least 24 hours to consent to study participation. Exclusion Criteria: Age < 16 years Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as: Chronic inflammatory skin condition Chronic liver failure Chronic renal failure Blood-borne viruses (Hep B, Hep C, HIV) Peripheral vascular disease Clinically significant anaemia Uncontrolled diabetes Need for use of the same harvest site (re-cropping) History of radiation therapy to proposed donor site Chronic use of medications known to impair wound healing Chronic use of opioids or neuropathic pain agents Suspected cellulitis, osteomyelitis or septicaemia Patients undergoing haemodialysis Patients requiring spinal/regional block Patients on current anti-coagulant therapy Unable or unwilling to provide informed consent Unable or unwilling to comply with the study follow-up schedule, and procedures Simultaneously participating in another investigational drug or device study (patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrolment in this study) Allergy or hypersensitivity to materials that are porcine-based Cultural or religious objection to the use of pig or porcine products Known intolerance/allergy to standard wound care products Presence of a local infection at the donor site and/or systemic infection

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A patient is suitable for inclusion in the study if the patient meets the following criteria, based on known information at the time of enrolment: 1. Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oasis ECM<br>The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application Oasis Extracellular Matrix to their donor site wound. | Device: Oasis ECM<br>* The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of Oasis Extracellular Matrix to their donor site wound.<br>|
| Active Comparator: Standard wound care<br>The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of standard wound care to their donor site wound. | Other: standard wound care<br>* The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of standard wound care to their donor site wound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor site wound healing | To demonstrate the percentage of patients with wounds healed at day 14 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of pain, analgesic usage | Patient will record daily usage of analgesics in a diary, daily, over the first 14 days post-treatment | 14 days | 
| Amount of pain, patient perceived | Patient will use the Visual Analog Score (VAS) to record pain in a diary, daily, over the first 14 days post-treatment. | 14 days | 
| Cosmetic Outcome utilizing POSAS | Cosmesis of the donor site wound will be assessed 3- and 6-months post-treatment by using the Patient and Observer Scar Assessment Scale (POSAS). | up to 6 months | 
| Adverse Events | Summary of adverse events reported | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Donor Site Wound