Oasis Donor Site Wounds Post-Market Study

Cook Group

Status: Enrolling

Conditions: Wound; Surgical Wound; Wound Heal; Wounds and Injuries

Treatments: Device: Oasis ECM; Other: standard wound care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04079348

19-001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Oasis ECM

Active Comparator group

Description:

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.

Treatment:

Device: Oasis ECM

Standard wound care

Active Comparator group

Description:

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.

Treatment:

Other: standard wound care