Non-melanoma Skin CancerNCT02409628
EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
A study testing EktoTherix in people with Non-melanoma Skin Cancer and Basal Cell Carcinoma, run by Neotherix Limited at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- EktoTherix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 23 Apr 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
3 sites in 1 country.
United Kingdom3 sites
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, North Yorkshire, TS4 3BW
Scarborough Hospital, York Teaching Hospital NHS Foundation Trust
Scarborough, North Yorkshire, YO12 6QL
The York Hospital, York Teaching Hospital NHS Foundation Trust
York, North Yorkshire, YO31 8HE
About this study
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.
Read more
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.
- Being tested
- EktoTherix
- 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
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EktoTherixDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EktoTherix | Experimental | One application of the EktoTherix scaffold to a fresh wound resulting from a full thickness excision of skin cancer. Receives: Device: EktoTherix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device related adverse events
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.
Measured: 3 months
Secondary outcomes (1)
Cosmesis (cosmetic outcome is assessed by the Vancouver Burn Scar Assessment Scale (VBSAS) score (clinician's assessment) and by a Visual Analogue Scale (VAS)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start23 Apr 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-melanoma Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neotherix Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lorien Engineering Solutions (a division of GP Strategies Ltd), Smith & Nephew Advanced Wound Management, NAMSA, Innovate UK
- Responsible party
- Sponsor
- Investigators
- Calum C Lyon, BSc BA MA MB BChir MRCP FRCP, Principal investigator, York Teaching Hospital NHS Foundation TrustMichael J Raxworthy, BSc PhD MBA, Study director, Neotherix Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409628
- Sponsor's protocol ID
- EKT01
- Status last verified
- Sep 2017
- First submitted
- 1 Apr 2015
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 2373734
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
- ClinicalTrials.gov ID
- NCT02409628
- Acronym / sponsor ID
- EKT01
- Keywords
- Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma, Surgical excision, EktoTherix, Secondary intention healing, Acute wound repair, Tissue repair scaffold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Neotherix LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Lorien Engineering Solutions (a division of GP Strategies Ltd), Smith & Nephew Advanced Wound Management, NAMSA, Innovate UK
- Study start
- 23 Apr 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EktoTherix | Experimental | Device: EktoTherixOne application of the EktoTherix scaffold to a fresh wound resulting from a full thickness excision of skin cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EktoTherixThe 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. | Device | EktoTherix |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Background: PubMed 2373734Sullivan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calum C Lyon, BSc BA MA MB BChir MRCP FRCP principal investigator
York Teaching Hospital NHS Foundation Trust
Michael J Raxworthy, BSc PhD MBA study director
Neotherix Limited
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EktoTherix in people with Non-melanoma Skin Cancer and Basal Cell Carcinoma, run by Neotherix Limited at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device related adverse events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.