Manchester University NHS Foundation Trust
Manchester, England, M13 9WL, United Kingdom
Location status: Recruiting
Location contact
Jacky Edwards, Bsc
SUB_INVESTIGATOR
Zeeshan Sheikh, MB ChB
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT04079348
Oasis Donor Site Wounds Post-Market Study
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Patients requiring spinal/regional block
- Patients on current anti-coagulant therapy
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with the study follow-up schedule, and procedures
- 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)
- Allergy or hypersensitivity to materials that are porcine-based
- Cultural or religious objection to the use of pig or porcine products
- Known intolerance/allergy to standard wound care products
- Presence of a local infection at the donor site and/or systemic infection
Treatment and study plan
Oasis ECM
DeviceThe 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
OtherThe 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.
Primary outcomes
-
Donor site wound healing
Time frame: 14 days
To demonstrate the percentage of patients with wounds healed at day 14
Secondary outcomes
-
Amount of pain, analgesic usage
Time frame: 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
Time frame: 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
Time frame: 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).
-
Adverse Events
Time frame: up to 6 months
Summary of adverse events reported
Study contacts
Contact information is provided by the study sponsor or research team.
Carina Gregory, MS
CONTACT
Rae Ritchie, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Cook Biotech Incorporated
Industry
Registry information
Official study title
Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds
Important dates
- Study start
- 2020
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Sep 6, 2019
- Registry last updated
- Dec 17, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Active, Not Recruiting
Chlorhexidine Plus Hyaluronic Acid Mouthwash in Surgical Wound Healing Following Third Molar Surgery
NCT05414253
Impacted Third Molar Tooth, Mouth Diseases
Pisa, Italy
View Trial Details
Completed
To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site
NCT06558240
Cesarean Section, Genital Diseases
Taipei, Taiwan
View Trial Details
Completed
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
NCT03274466
Infection, Infections
Weston, Florida, United States
View Trial Details
Enrolling by Invitation
BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation
NCT07611318
DFU, Pressure Injuries
San Diego, California, United States
View Trial Details