EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds

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.

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma; Non-melanoma Skin Cancer
• Intervention / Treatment: Device: EktoTherix

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • North Yorkshire
    • Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
      • The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
    • Scarborough, North Yorkshire, United Kingdom, YO12 6QL
      • Scarborough Hospital, York Teaching Hospital NHS Foundation Trust
    • York, North Yorkshire, United Kingdom, YO31 8HE
      • The York Hospital, York Teaching Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Neotherix Limited
• Collaborators: NAMSA; Innovate UK; Lorien Engineering Solutions (a division of GP Strategies Ltd); Smith & Nephew Advanced Wound Management
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Squamous Cell Carcinoma; Basal Cell Carcinoma; Non-melanoma Skin Cancer; Surgical excision; EktoTherix; Secondary intention healing; Acute wound repair; Tissue repair scaffold; Regenerative medicine scaffold; Electrospun scaffold
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Squamous Cell; Skin Neoplasms; Carcinoma, Basal Cell
• Other Study ID Numbers: EKT01