Trials / Completed
CompletedNCT02409628
EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Neotherix Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-04-23
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2015-04-07
- Last updated
- 2017-09-15
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02409628. Inclusion in this directory is not an endorsement.