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Oasis Donor Site Wounds Post-Market Study

Sponsor: Cook Biotech Incorporated

NCT ID: NCT04079348

View on ClinicalTrials.gov ↗

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.

Surgical WoundWoundWounds and InjuriesWound Heal

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What we know so far

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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
Inclusion Criteria: 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. 2. Has at least 24 hours to consent to study participation. Exclusion Criteria: 1. Age \< 16 years 2. Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as: 1. Chronic inflammatory skin condition 2. Chronic liver failure 3. Chronic renal failure 4. Blood-borne viruses (Hep B, Hep C, HIV) 5. Peripheral vascular disease 6. Clinically significant anaemia 7. Uncontrolled diabetes 3. Need for use of the same harvest site (re-cropping) 4. History of radiation therapy to proposed donor site 5. Chronic use of medications known to impair wound healing 6. Chronic use of opioids or neuropathic pain agents 7. Suspected cellulitis, osteomyelitis or septicaemia 8. Patients undergoing haemodialysis 9. Patients requiring spinal/regional block 10. Patients on current anti-coagulant therapy 11. Unable or unwilling to provide informed consent 12. Unable or unwilling to comply with the study follow-up schedule, and procedures 13. 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) 14. Allergy or hypersensitivity to materials that are porcine-based 15. Cultural or religious objection to the use of pig or porcine products 16. Known intolerance/allergy to standard wound care products 17. Presence of a local infection at the donor site and/or systemic infection

Where Is This Study? (1 UK site)

Manchester University NHS Foundation Trust

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)
Zeeshan Sheikh, MB ChBPrincipal Investigator

How to Get in Touch

Carina Gregory, MS

Sponsor contact

CONTACT

765-497-3355 cgregory@rtix.com

Rae Ritchie, PhD

Sponsor contact

CONTACT

765-497-3355 rritchie@rtix.com
Data sourced from ClinicalTrials.gov · Last verified: 2024-12