Oasis Donor Site Wounds Post-Market Study

Not Applicable

Recruiting

• Conditions: Wounds and Injuries; Surgical Wound; Wound; Wound Heal
• Interventions: Other: standard wound care; Device: Oasis ECM

• Registration Number: NCT04079348
• Lead Sponsor: Cook Biotech Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2020-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard wound care	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.
Oasis ECM	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.

Primary Outcome Measures

Name	Time	Method
Donor site wound healing	14 days	To demonstrate the percentage of patients with wounds healed at day 14

Secondary Outcome Measures

Name	Time	Method
Adverse Events	up to 6 months	Summary of adverse events reported
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).

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, England, United Kingdom