Endoform (Trademark) Regenerative Template – Tumour Resection Case Studies (MESCS102)

Cosmetic Outcomes Following the Use of Endoform(Trademark) Regenerative Template in Single-Stage Split Thickness Grafting Procedures Following Tumor Resection

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000047998

Enrollment

Registered

2011-01-13

Start date

2011-01-31

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aims of the study are to find out whether the new type of medical device is acceptable to participants and plastic surgeons for use during the removal of cancerous skin tumours. The study aims to understand if the device leads to acceptable cosmetic outcomes (e.g. reduced scarring) following use. The study product is called the Endoform Regenerative Template. The device is made mainly from collagen, a protein that also occurs naturally in the human body. Studies have shown that collagen-based products can trigger cell movement into a wound and improve the speed and quality of wound healing. Collagen based products have been used extensively to help close the defect following the removal of skin tumours. The Endoform Regenerative Template is a new product which has not previously been used to repair surgical sites following removal of tumors. Endoform has however been used to treat a number of wounds including chronic venous and diabetic ulcers. The use of the Endoform Regenerative Template following tumour resection could potentially reduce the surgical time, time to wound healing and improve the quality of the healed wound.

Interventions

Study participants will recieve a full thickness tumor resection. Endoform (Trademark) Regenerative Template (Ovine forestomach matrix) will be applied to the tissue deficit and the split skin graft applied to the ovine forestomach matrix. The wound will be dressed according to standard care. Participants will receive one surgical procedure and will be subsequently examined at 1, 3, and 6 months.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. >18 years old. 2. At least one non-melanoma skin cancer without metastatic disease. 3. Malignancies that require full-thickness excision. 4. Post excision wounds that would normally be reconstructed with a split skin graft. 5. Compliant. 6. Competent. 7. Tumour located on the scalp, neck or upper limbs.

Exclusion criteria

1. Any cutaneous malignancies with metastatic disease. 2. Diagnosed with malignant melanoma. 3. Systemic malignancy. 4. Under suspicion of metastatic disease. 5. Pregnant or lactating. 6. Clinically significant cardiac, pulmonary, renal, hepatic, neurologic and/or immune dysfunction that may affect wound healing. 7. Known allergy to collagen or ovine (sheep) materials. Any previous reaction to a collagen product. 8. Family or personal history of severe allergies (including asthma, hay fever and atopic dermatitis). 9. Allergies to foods, especially meat products. 10. Unable to remain in study for 6 months. 11. Diabetes mellitus. 12. Declined, unable or unwilling to make informed consent. 13. Not fluent in English or Maori – requires interpreter. 14. Religious or ethical objections to sheep-derived product. 15. Previous radiotherapy at the defect site. 16. Immunosuppressant medication (prednisone >5mg /day or equivalent).

Outcome results