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EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02409628
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : September 15, 2017
Sponsor:
Collaborators:
Lorien Engineering Solutions (a division of GP Strategies Ltd)
Smith & Nephew Advanced Wound Management
NAMSA
Innovate UK
Information provided by (Responsible Party):
Neotherix Limited

Study Description
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Brief Summary:

The purpose of study is to assess the safety and performance of EktoTherix™ Tissue Repair Scaffold in the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers.

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.


Condition or disease Intervention/treatment Phase
Non-melanoma Skin Cancer Basal Cell Carcinoma Squamous Cell Carcinoma Device: EktoTherix Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
Actual Study Start Date : April 23, 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: EktoTherix
One application of the EktoTherix scaffold to a fresh wound resulting from a full thickness excision of skin cancer.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of device related adverse events [ Time Frame: 3 months ]
    The primary endpoint of the study is to demonstrate the safety of the EktoTherix Tissue Repair Scaffold through the incidence of device related adverse events identified during the study, including clinical infection, whether the wound has healed by the final clinical assessment and any clinically significant laboratory results at three month post-surgery assessment.


Secondary Outcome Measures :
  1. Cosmesis (cosmetic outcome is assessed by the Vancouver Burn Scar Assessment Scale (VBSAS) score (clinician's assessment) and by a Visual Analogue Scale (VAS) [ Time Frame: 3 months ]

    The cosmetic outcome is assessed by the Vancouver Burn Scar Assessment Scale (VBSAS) score (clinician's assessment) and by a Visual Analogue Scale (VAS) score (patient's assessment). The VBSAS scale assigns a numerical score by summing individual ratings for pigmentation, vascularity, pliability and height or depression of the wound or scar. The VAS score is a number, between the worst (0) and the best (ten) cosmetic outcome, representing the patient's perception of the treatment.

    The cosmetic outcome is evaluated when the wound is healed (if prior to or on Day 42 Post-surgery Assessment) and at the 3 Month Post-surgery Assessment.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is the patient at least 18 years of age
  • 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 any transmittable viral diseases (HIV, Hepatitis B or C)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409628


Locations
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United Kingdom
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
Scarborough Hospital, York Teaching Hospital NHS Foundation Trust
Scarborough, North Yorkshire, United Kingdom, YO12 6QL
The York Hospital, York Teaching Hospital NHS Foundation Trust
York, North Yorkshire, United Kingdom, YO31 8HE
Sponsors and Collaborators
Neotherix Limited
Lorien Engineering Solutions (a division of GP Strategies Ltd)
Smith & Nephew Advanced Wound Management
NAMSA
Innovate UK
Investigators
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Principal Investigator: Calum C Lyon, BSc BA MA MB BChir MRCP FRCP York Teaching Hospital NHS Foundation Trust
Study Director: Michael J Raxworthy, BSc PhD MBA Neotherix Limited
More Information
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Publications:

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Responsible Party: Neotherix Limited
ClinicalTrials.gov Identifier: NCT02409628    
Other Study ID Numbers: EKT01
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Keywords provided by Neotherix Limited:
Non-melanoma Skin Cancer
Basal Cell Carcinoma
Squamous Cell Carcinoma
Surgical excision
EktoTherix
 Secondary intention healing
Acute wound repair
Tissue repair scaffold
Regenerative medicine scaffold
Electrospun scaffold
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases