Oasis Donor Site Wounds Post-Market Study

NCT04079348 | Recruiting FDA Device

• 1 other identifier: 19-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound; Wound; Wounds and Injuries; Wound Heal

Keywords

Donor Site Wound

Outcome Measures

Primary Outcomes (1)

• Donor site wound healing

  To demonstrate the percentage of patients with wounds healed at day 14

  14 days

Secondary Outcomes (4)

• Amount of pain, analgesic usage

  14 days

• Amount of pain, patient perceived

  14 days

• Cosmetic Outcome utilizing POSAS

  up to 6 months

• Adverse Events

  up to 6 months

Study Arms (2)

Oasis ECM

ACTIVE COMPARATOR

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

Standard wound care

ACTIVE COMPARATOR

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

Interventions

Oasis ECM DEVICE

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.

Oasis ECM

standard wound care OTHER

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.

Standard wound care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Has at least 24 hours to consent to study participation.

You may not qualify if:

• Age \< 16 years
• Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:
• Chronic inflammatory skin condition
• Chronic liver failure
• Chronic renal failure
• Blood-borne viruses (Hep B, Hep C, HIV)
• Peripheral vascular disease
• Clinically significant anaemia
• Uncontrolled diabetes
• Need for use of the same harvest site (re-cropping)
• History of radiation therapy to proposed donor site
• Chronic use of medications known to impair wound healing
• Chronic use of opioids or neuropathic pain agents
• Suspected cellulitis, osteomyelitis or septicaemia
• Patients undergoing haemodialysis

Sponsors & Collaborators

• Cook Biotech Incorporated: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, England, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Surgical Wound; Wounds and Injuries

Central Study Contacts

Carina Gregory, MS

CONTACT

765-497-3355; cgregory@rtix.com

Rae Ritchie, PhD

CONTACT

765-497-3355; rritchie@rtix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization to treatment groups will be performed using a computer system to randomly assign subjects to treatment arms. Sealed envelopes numbered 1-40 will be provided to the study site. Patients will be assigned an envelope number upon providing informed consent. The envelope will be opened during the treatment procedure to minimize the risk of bias in patient assignment to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A patient is suitable for inclusion in the study if the patient meets the following criteria, based on known information at the time of enrolment: 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.

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: November 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)