EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
NCT ID: NCT02409628
Last Updated: 2017-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2015-04-23
2017-07-31
Brief Summary
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EktoTherix™ is a medical device developed by Neotherix Limited, manufactured by the polymer processing technique of electrospinning. Described as a "tissue scaffold", EktoTherix is placed into the surgical wound to help the patients' own cells repair the wound, enhancing healing and improving quality (including cosmetic outcome). The tissue scaffold is completely absorbed by the body during the healing process, which means that there is no need to remove it when the wound is healed.
All patients recruited into this study are treated with EktoTherix, are seen weekly until they heal and seen again at the final follow-up visit three months post-surgery.
The investigators hypothesise that the use of EktoTherix will increase incidence of complete healing and result in an overall better cosmetic result of the healed wound.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EktoTherix
One application of the EktoTherix scaffold to a fresh wound resulting from a full thickness excision of skin cancer.
EktoTherix
The EktoTherix scaffold is applied to the fresh wound resulting from a full thickness excision of non-melanoma skin cancer and then bolstered by the application of a non-adhesive foam dressing (discontinued at the first visit); both scaffold and foam dressing are secured in place using a semi-occlusive film dressing. The EktoTherix-treated wound is assessed weekly as per standard of care.
Interventions
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EktoTherix
The EktoTherix scaffold is applied to the fresh wound resulting from a full thickness excision of non-melanoma skin cancer and then bolstered by the application of a non-adhesive foam dressing (discontinued at the first visit); both scaffold and foam dressing are secured in place using a semi-occlusive film dressing. The EktoTherix-treated wound is assessed weekly as per standard of care.
Eligibility Criteria
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Inclusion Criteria
* Is the patient male, or is not pregnant or lactating and is using contraception
* Has the patient been diagnosed with a non-melanoma skin cancer (basal cell carcinoma BCC or squamous cell carcinoma SCC) for which the chosen therapeutic option is surgical excision followed by secondary intention healing
* Is the excisional wound greater than 10mm x 10mm in size and less than or equal to 35mm x 35mm after any attempt at primary closure
* Does the patient have limited skin laxity which would make primary closure of the surgical excision difficult
* Is the patient able to understand the aims and objectives of the trial and are they willing to consent
Exclusion Criteria
* Has the patient been diagnosed with, or is it suspected that they have metastatic disease
* Does the patient have a history of malignant melanoma or any concomitant disease likely to impede wound healing
* Has the patient been diagnosed with pre-existing wound infection
* Is the patient taking any medication known to interfere with skin grafts (i.e. warfarin and other anticoagulants, steroids, NSAIDs and immunosuppressants)
* Has the excised wound been entirely treated by primary closure
* Does the patient have a history of any significant cardiac, pulmonary, renal, hepatic, neurological and/ or immune dysfunction that may affect wound healing
* Does the patient know of any allergy to any of the device materials to be used in the trial
* Does the patient have a known history of poor compliance with medical treatment
* Has the patient participated in this trial previously and healed or been withdrawn
* Is the patient currently participating in any other clinical trial
18 Years
ALL
No
Sponsors
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Lorien Engineering Solutions (a division of GP Strategies Ltd)
UNKNOWN
Smith & Nephew Advanced Wound Management
UNKNOWN
NAMSA
OTHER
Innovate UK
OTHER_GOV
Neotherix Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Calum C Lyon, BSc BA MA MB BChir MRCP FRCP
Role: PRINCIPAL_INVESTIGATOR
York Teaching Hospital NHS Foundation Trust
Michael J Raxworthy, BSc PhD MBA
Role: STUDY_DIRECTOR
Neotherix Limited
Locations
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The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, North Yorkshire, United Kingdom
Scarborough Hospital, York Teaching Hospital NHS Foundation Trust
Scarborough, North Yorkshire, United Kingdom
The York Hospital, York Teaching Hospital NHS Foundation Trust
York, North Yorkshire, United Kingdom
Countries
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References
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Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
Other Identifiers
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EKT01
Identifier Type: -
Identifier Source: org_study_id