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Recruiting NCT04079348

Oasis Donor Site Wounds Post-Market Study

No phase Interventional Surgical Wound Wound Wounds and Injuries Wound Heal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oasis ECM, standard wound care.
Who it may be relevant to
Registry conditions: Surgical Wound, Wound, Wounds and Injuries, Wound Heal. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds

Overview

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.

Interventions

  • Device Oasis ECM
    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.
  • Other standard wound care
    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 measures

  • Donor site wound healing [Time frame: 14 days]
Secondary outcome measures (4)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Manchester University NHS Foundation Trust — Manchester

Identifiers

NCT: NCT04079348 · 19-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗