Oasis Donor Site Wounds Post-Market Study

Overview

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.

Full Title of Study: “Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2021

Interventions

  • Device: Oasis 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.
  • Other: standard 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.

Arms, Groups and Cohorts

  • Active Comparator: Oasis ECM
    • 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.
  • Active Comparator: Standard 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.

Clinical Trial Outcome Measures

Primary Measures

  • Donor site wound healing
    • Time Frame: 14 days
    • To demonstrate the percentage of patients with wounds healed at day 14

Secondary Measures

  • Amount of pain, analgesic usage
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: up to 6 months
    • Summary of adverse events reported

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cook Biotech Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jason Hodde, MS, 765-497-3355, jason.hodde@cookbiotech.com

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