EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds

Neotherix

Status: Completed

Conditions: Squamous Cell Carcinoma; Non-melanoma Skin Cancer; Basal Cell Carcinoma

Treatments: Device: EktoTherix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02409628

EKT01

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

EktoTherix

Experimental group

Description:

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

Treatment:

Device: EktoTherix