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EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds

Primary Purpose

Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EktoTherix
Sponsored by
Neotherix Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-melanoma Skin Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
  • Scarborough Hospital, York Teaching Hospital NHS Foundation Trust
  • The York Hospital, York Teaching Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EktoTherix

Arm Description

One application of the EktoTherix scaffold to a fresh wound resulting from a full thickness excision of skin cancer.

Outcomes

Primary Outcome Measures

Incidence of device related adverse events
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

Cosmesis (cosmetic outcome is assessed by the Vancouver Burn Scar Assessment Scale (VBSAS) score (clinician's assessment) and by a Visual Analogue Scale (VAS)
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.

Full Information

First Posted
April 1, 2015
Last Updated
September 14, 2017
Sponsor
Neotherix Limited
Collaborators
Lorien Engineering Solutions (a division of GP Strategies Ltd), Smith & Nephew Advanced Wound Management, NAMSA, Innovate UK
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1. Study Identification

Unique Protocol Identification Number
NCT02409628
Brief Title
EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
Official Title
EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 23, 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neotherix Limited
Collaborators
Lorien Engineering Solutions (a division of GP Strategies Ltd), Smith & Nephew Advanced Wound Management, NAMSA, Innovate UK

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EktoTherix
Arm Type
Experimental
Arm Description
One application of the EktoTherix scaffold to a fresh wound resulting from a full thickness excision of skin cancer.
Intervention Type
Device
Intervention Name(s)
EktoTherix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of device related adverse events
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cosmesis (cosmetic outcome is assessed by the Vancouver Burn Scar Assessment Scale (VBSAS) score (clinician's assessment) and by a Visual Analogue Scale (VAS)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Calum C Lyon, BSc BA MA MB BChir MRCP FRCP
Organizational Affiliation
York Teaching Hospital NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J Raxworthy, BSc PhD MBA
Organizational Affiliation
Neotherix Limited
Official's Role
Study Director
Facility Information:
Facility Name
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
State/Province
North Yorkshire
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Scarborough Hospital, York Teaching Hospital NHS Foundation Trust
City
Scarborough
State/Province
North Yorkshire
ZIP/Postal Code
YO12 6QL
Country
United Kingdom
Facility Name
The York Hospital, York Teaching Hospital NHS Foundation Trust
City
York
State/Province
North Yorkshire
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
2373734
Citation
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.
Results Reference
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EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds

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