EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
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| ClinicalTrials.gov Identifier: NCT02409628 |
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Recruitment Status :
Completed
First Posted : April 7, 2015
Last Update Posted : September 15, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-melanoma Skin Cancer Basal Cell Carcinoma Squamous Cell Carcinoma | Device: EktoTherix | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds |
| Actual Study Start Date : | April 23, 2015 |
| Actual Primary Completion Date : | July 2017 |
| Actual Study Completion Date : | July 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: EktoTherix
One application of the EktoTherix scaffold to a fresh wound resulting from a full thickness excision of skin cancer.
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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. |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409628
| United Kingdom | |
| The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust | |
| Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW | |
| Scarborough Hospital, York Teaching Hospital NHS Foundation Trust | |
| Scarborough, North Yorkshire, United Kingdom, YO12 6QL | |
| The York Hospital, York Teaching Hospital NHS Foundation Trust | |
| York, North Yorkshire, United Kingdom, YO31 8HE | |
| 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:
| Responsible Party: | Neotherix Limited |
| ClinicalTrials.gov Identifier: | NCT02409628 History of Changes |
| Other Study ID Numbers: |
EKT01 |
| First Posted: | April 7, 2015 Key Record Dates |
| Last Update Posted: | September 15, 2017 |
| Last Verified: | September 2017 |
Keywords provided by Neotherix Limited:
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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 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Carcinoma, Basal Cell Skin Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Squamous Cell Neoplasms, Basal Cell Neoplasms by Site Skin Diseases |