Clinical trial NCT02409628: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Neotherix Limited
Sponsor class: INDUSTRY
Collaborators: name: Lorien Engineering Solutions (a division of GP Strategies Ltd)
name: Smith & Nephew Advanced Wound Management
name: NAMSA
name: Innovate UK
First posted: 2015-04-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of device related adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Cosmesis (cosmetic outcome is assessed by the Vancouver Burn Scar Assessment Scale (VBSAS) score (clinician's assessment) and by a Visual Analogue Scale (VAS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
state: North Yorkshire
city: Scarborough
country: United Kingdom
facility: Scarborough Hospital, York Teaching Hospital NHS Foundation Trust
state: North Yorkshire
city: York
country: United Kingdom
facility: The York Hospital, York Teaching Hospital NHS Foundation Trust
state: North Yorkshire
Study officials:
affiliation: York Teaching Hospital NHS Foundation Trust
name: Calum C Lyon, BSc BA MA MB BChir MRCP FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Neotherix Limited
name: Michael J Raxworthy, BSc PhD MBA
role: STUDY_DIRECTOR
References:
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.