Surgical WoundNCT04079348
Oasis Donor Site Wounds Post-Market Study
A study testing Oasis ECM and standard wound care in people with Surgical Wound and Wound, run by Cook Biotech Incorporated at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgical Wound, Wound, Wounds and Injuries
- What is being tested?
- Oasis ECM and standard wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, England, M13 9WL
Zeeshan Sheikh, MB ChB
Jacky Edwards, Bsc
About this study
Official title: Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds
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
- Being tested
- Oasis ECM, standard wound care
- Keywords
- Donor Site Wound
- Medical subject headings
- Surgical Wound, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oasis ECMDevice
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: standard wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor site wound healing
To demonstrate the percentage of patients with wounds healed at day 14
Measured: 14 days
Secondary outcomes (4)
Amount of pain, analgesic usage
Patient will record daily usage of analgesics in a diary, daily, over the first 14 days post-treatment
Measured: 14 days
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.
Measured: 14 days
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).
Measured: up to 6 months
Adverse Events
Summary of adverse events reported
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Nov 2020
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook Biotech Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079348
- Sponsor's protocol ID
- 19-001
- Status last verified
- Dec 2024
- First submitted
- 3 Sep 2019
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds
- ClinicalTrials.gov ID
- NCT04079348
- Acronym / sponsor ID
- 19-001
- Conditions
- Surgical Wound, Wound, Wounds and Injuries, Wound Heal
- Keywords
- Donor Site Wound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cook Biotech IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oasis ECM | Active comparator | Device: Oasis ECMThe 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. |
| Standard wound care | Active comparator | Other: standard wound careThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (24 listed)
- Age < 16 years
- Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oasis ECMThe 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. | Device | Oasis ECM |
| standard wound careThe 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 |
Primary outcome
Donor site wound healing
Time frame: 14 days
To demonstrate the percentage of patients with wounds healed at day 14
4 secondary outcomes
Amount of pain, analgesic usage
Time frame: 14 days
Amount of pain, patient perceived
Time frame: 14 days
Cosmetic Outcome utilizing POSAS
Time frame: up to 6 months
Adverse Events
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oasis ECM and standard wound care in people with Surgical Wound and Wound, run by Cook Biotech Incorporated at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carina Gregory, MS (765-497-3355, cgregory@rtix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor site wound healing (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.