Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Oxytetracycline

Mohs micrographic surgery + Autologus patch formed from 18 ml venous blood sample collected from the patient + polymycin-terramycin B ointment and a Jelonet applied on top of the patch.

Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing

A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.

MMS + Autologous patch

Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)

MMS and secondary intention healing

Katrine E Karmisholt, MD, PhD

Anna A Harager, Bsc

Katrine E Karmisholt, Ph.D.

Anna A Harager

The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.

Blinded photo assesment of wound healing by two independent trained clinical doctors.

Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery

Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial

Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no.

Clinical photos from day 11-13 will be evaluated. Wounds will be evaluated 50% fully epithelialized yes/no.

Trans epidermal water loss (TEWL) will be meassured at day 11-13 and day 18-20. The TEWL will be meassured on the wound healing site and the contralateral site of the patient's face as a control.

The POSAS observer scores scar components with regards to: Vascularity, pigmentation, thickness, surface area, relief and pliability. The collected sum of scores will range from minimum 6 points to maximum 60 points.

Swab test for microbiome analysis will be conducted at day 1 and day 11-13.

Benzon Foundation

Bispebjerg Hospital

MD, Chief Consultant, Ass.Prof., PhD

Wounds and Injuries

Rare Diseases

Carcinoma, Squamous Cell

Neoplasms, Squamous Cell

Acute Graft Versus Host Disease

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.

EktoTherix

Calum C Lyon, BSc BA MA MB BChir MRCP FRCP

Michael J Raxworthy, BSc PhD MBA

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.

EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery	NCT05170035	Skin Cancer Basal Cell Carc...	MMS + Autologou... MMS and seconda...	18 Years - 100 Years	Bispebjerg Hospital
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery	NCT05170035	Skin Cancer Basal Cell Carc...	MMS + Autologou... MMS and seconda...	18 Years - 100 Years	Bispebjerg Hospital
EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds	NCT02409628	Non-melanoma Sk... Basal Cell Carc... Squamous Cell C...	EktoTherix	18 Years -	Neotherix Limited

Spots Global Cancer Trial Database for secondary intention healing