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.

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Key information

Conditions

Non-Melanoma Skin Cancer Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, North Yorkshire, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EktoTherix

Device

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 outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Neotherix Limited

Industry

Collaborators

Innovate UK
Lorien Engineering Solutions (a division of GP Strategies Ltd)
NAMSA
Smith & Nephew Advanced Wound Management

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Apr 7, 2015
Registry last updated: Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed