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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oasis ECM | Active Comparator | 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. |
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| Standard wound care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oasis ECM | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Donor site wound healing | To demonstrate the percentage of patients with wounds healed at day 14 | 14 days |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Age < 16 years
Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carina Gregory, MS | Contact | 765-497-3355 | cgregory@rtix.com | |
| Rae Ritchie, PhD | Contact | 765-497-3355 | rritchie@rtix.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester University NHS Foundation Trust | Recruiting | Manchester | England | M13 9WL | United Kingdom |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D014947 | Wounds and Injuries |
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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.
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Randomization to treatment groups will be performed using a computer system to randomly assign subjects to treatment arms. Sealed envelopes numbered 1-40 will be provided to the study site. Patients will be assigned an envelope number upon providing informed consent. The envelope will be opened during the treatment procedure to minimize the risk of bias in patient assignment to the treatment group.
| standard wound care | Other | 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. |
|
| 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 |