NCT02409628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

April 23, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

April 1, 2015

Last Update Submit

September 14, 2017

Conditions

Non-melanoma Skin CancerBasal Cell CarcinomaSquamous Cell Carcinoma

Keywords

Non-melanoma Skin CancerBasal Cell CarcinomaSquamous Cell CarcinomaSurgical excisionEktoTherixSecondary intention healingAcute wound repairTissue repair scaffoldRegenerative medicine scaffoldElectrospun scaffold

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    3 months

Study Arms (1)

EktoTherix

EXPERIMENTAL

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

Device: EktoTherix

Interventions

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.

EktoTherix

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust

Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

Location

Scarborough Hospital, York Teaching Hospital NHS Foundation Trust

Scarborough, North Yorkshire, YO12 6QL, United Kingdom

Location

The York Hospital, York Teaching Hospital NHS Foundation Trust

York, North Yorkshire, YO31 8HE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 2373734BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal CellCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms, Squamous Cell

Study Officials

  • Calum C Lyon, BSc BA MA MB BChir MRCP FRCP

    York Teaching Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Michael J Raxworthy, BSc PhD MBA

    Neotherix Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 7, 2015

Study Start

April 23, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

GB(3)