Oasis Donor Site Wounds Post-Market Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wounds and Injuries; Surgical Wound; Wound Heal; Wound
• Intervention / Treatment: Device: Oasis ECM; Other: standard wound care

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carina Gregory, MS; Phone Number: 765-497-3355; Email: cgregory@rtix.com
• Study Contact Backup: Name: Rae Ritchie, PhD; Phone Number: 765-497-3355; Email: rritchie@rtix.com

Study Locations

• United Kingdom
  • England
    • Manchester, England, United Kingdom, M13 9WL
      • Recruiting
      • Manchester University NHS Foundation Trust
      • Principal Investigator: Zeeshan Sheikh, MB ChB
      • Sub-Investigator: Jacky Edwards, Bsc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cook Biotech Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Donor Site Wound
• Additional Relevant MeSH Terms: Surgical Wound; Wounds and Injuries
• Other Study ID Numbers: 19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes