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EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds

NCT02409628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-09-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Lorien Engineering Solutions (a division of GP Strategies Ltd)

    collaborator UNKNOWN

  • Smith & Nephew Advanced Wound Management

    collaborator UNKNOWN

  • NAMSA

    collaborator OTHER

  • Innovate UK

    collaborator OTHER_GOV

  • Neotherix Limited

    lead INDUSTRY

Principal Investigators

  • Calum C Lyon, BSc BA MA MB BChir MRCP FRCP · York Teaching Hospital NHS Foundation Trust

  • Michael J Raxworthy, BSc PhD MBA · Neotherix Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-23
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02409628 on ClinicalTrials.gov