Oasis Donor Site Wounds Post-Market Study

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04079348
• Other study ID #: 19-001
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Cook Biotech Incorporated
• Contact: Jason Hodde, MS
• Phone: 765-497-3355
• Email: jhodde[@]rtix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Wound
• Wound Heal
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
Cook Biotech Incorporated

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Donor site wound healing	To demonstrate the percentage of patients with wounds healed at day 14	14 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events	Summary of adverse events reported	up to 6 months