At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Oasis ECM (device), standard wound care (other)
- How long the study runs
- Study runs about 61 months (dates as stated)
- About the drug or intervention
- 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. · 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 40
- Started
- 2020-11-01
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for surgical wound
- • NA - 40 participants
- • 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
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with surgical wound
Where?
- • Manchester - Manchester University NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a...
- ✓Has at least 24 hours to consent to study participation.
Who cannot take part
- ✗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 kidney failure
See the full criteria
Where Is This Study? (1 UK site)
Manchester University NHS Foundation Trust
Manchester M13 9WL, United Kingdom
How to Get in Touch
Carina Gregory, MS
Sponsor contactCONTACT
Rae Ritchie, PhD
Sponsor contactCONTACT
