Surgical Wound, Wound, Wound Heal, Wounds and Injuries
Conditions
Keywords
Donor Site Wound
Brief summary
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.
Interventions
DEVICEOasis ECM
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.
OTHERstandard wound care
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.
Sponsors
Cook Biotech Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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. 2. Has at least 24 hours to consent to study participation.
Exclusion criteria
1. Age \< 16 years 2. Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as: 1. Chronic inflammatory skin condition 2. Chronic liver failure 3. Chronic renal failure 4. Blood-borne viruses (Hep B, Hep C, HIV) 5. Peripheral vascular disease 6. Clinically significant anaemia 7. Uncontrolled diabetes 3. Need for use of the same harvest site (re-cropping) 4. History of radiation therapy to proposed donor site 5. Chronic use of medications known to impair wound healing 6. Chronic use of opioids or neuropathic pain agents 7. Suspected cellulitis, osteomyelitis or septicaemia 8. Patients undergoing haemodialysis 9. Patients requiring spinal/regional block 10. Patients on current anti-coagulant therapy 11. Unable or unwilling to provide informed consent 12. Unable or unwilling to comply with the study follow-up schedule, and procedures 13. 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) 14. Allergy or hypersensitivity to materials that are porcine-based 15. Cultural or religious objection to the use of pig or porcine products 16. Known intolerance/allergy to standard wound care products 17. Presence of a local infection at the donor site and/or systemic infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donor site wound healing | 14 days | To demonstrate the percentage of patients with wounds healed at day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of pain, analgesic usage | 14 days | Patient will record daily usage of analgesics in a diary, daily, over the first 14 days post-treatment |
| Amount of pain, patient perceived | 14 days | Patient will use the Visual Analog Score (VAS) to record pain in a diary, daily, over the first 14 days post-treatment. |
| Cosmetic Outcome utilizing POSAS | up to 6 months | 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). |
| Adverse Events | up to 6 months | Summary of adverse events reported |
Countries
United Kingdom
Contacts
Primary ContactCarina Gregory, MS
Backup ContactRae Ritchie, PhD
Outcome results
None listed