EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
|ClinicalTrials.gov Identifier: NCT02409628|
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : September 15, 2017
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)|
|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|
One application of the EktoTherix scaffold to a fresh wound resulting from a full thickness excision of skin cancer.
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409628
|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|