Oasis Donor Site Wounds Post-Market Study
Primary Purpose
Surgical Wound, Wound, Wounds and Injuries
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Oasis ECM
standard wound care
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Wound focused on measuring Donor Site Wound
Eligibility Criteria
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
Sites / Locations
- Manchester University NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oasis ECM
Standard wound care
Arm 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.
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.
Outcomes
Primary Outcome Measures
Donor site wound healing
To demonstrate the percentage of patients with wounds healed at day 14
Secondary Outcome Measures
Amount of pain, analgesic usage
Patient will record daily usage of analgesics in a diary, daily, over the first 14 days post-treatment
Amount of pain, patient perceived
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
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
Summary of adverse events reported
Full Information
NCT ID
NCT04079348
First Posted
September 3, 2019
Last Updated
February 8, 2023
Sponsor
Cook Biotech Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT04079348
Brief Title
Oasis Donor Site Wounds Post-Market Study
Official Title
Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Biotech Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Wound, Wounds and Injuries, Wound Heal
Keywords
Donor Site Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oasis ECM
Arm Type
Active Comparator
Arm 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.
Arm Title
Standard wound care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Oasis ECM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard wound care
Intervention 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.
Primary Outcome Measure Information:
Title
Donor site wound healing
Description
To demonstrate the percentage of patients with wounds healed at day 14
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Amount of pain, analgesic usage
Description
Patient will record daily usage of analgesics in a diary, daily, over the first 14 days post-treatment
Time Frame
14 days
Title
Amount of pain, patient perceived
Description
Patient will use the Visual Analog Score (VAS) to record pain in a diary, daily, over the first 14 days post-treatment.
Time Frame
14 days
Title
Cosmetic Outcome utilizing POSAS
Description
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).
Time Frame
up to 6 months
Title
Adverse Events
Description
Summary of adverse events reported
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Hodde, MS
Phone
765-497-3355
Email
jason.hodde@cookbiotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Stevenson, BS
Phone
765-497-3355
Email
sstevenson@cookbiotech.com
Facility Information:
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeeshan Sheikh, MB ChB
First Name & Middle Initial & Last Name & Degree
Jacky Edwards, Bsc
12. IPD Sharing Statement
Plan to Share IPD
No
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Oasis Donor Site Wounds Post-Market Study
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