Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000047998
Ethics application status
Approved
Date submitted
13/01/2011
Date registered
13/01/2011
Date last updated
7/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Endoform (Trademark) Regenerative Template – Tumour Resection Case Studies (MESCS102)
Scientific title
Cosmetic Outcomes Following the Use of Endoform(Trademark) Regenerative Template in Single-Stage Split Thickness Grafting Procedures Following Tumor Resection
Secondary ID [1] 253396 0
URA/10/11/080 - Upper South A Regional Ethics Committee
Ministry of Health, 4th Floor, 250 Oxford Terrace, Christchurch, New Zealand
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermal regeneration following tumour resection 260951 0
Condition category
Condition code
Cancer 259088 259088 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257842 0
Treatment: Surgery
Intervention code [2] 257843 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259941 0
Assess the device for use as a substrate in a single-stage split skin graft procedure. Assessment will be conducted using a standardized clinical questionaire utilising semi-structured questions and free text. Clinical examination will be conducted during the course of the study by those trained in the art. Photographic images will be collected through the course of the study
Timepoint [1] 259941 0
0, 1, 3 and 6 months
Primary outcome [2] 259942 0
Evaluate healing outcomes including pain, scarring and cosmesis. Assessment will be conducted using a standardized clinical questionaire utilising semi-structured questions and free text. Clinical examination will be conducted during the course of the study by those trained in the art. Photographic images will be collected through the course of the study
Timepoint [2] 259942 0
0, 1, 3 and 6 months
Primary outcome [3] 259943 0
Define the procedural use of the device in single-stage SSG procedure. Assessment will be conducted using a standardized clinical questionaire utilising semi-structured questions and free text. Clinical examination will be conducted during the course of the study by those trained in the art. Photographic images will be collected through the course of the study
Timepoint [3] 259943 0
0, 1, 3 and 6 months
Secondary outcome [1] 268848 0
Document detailed written and pictorial case histories and make notes of particular clinical success.
Timepoint [1] 268848 0
0, 1, 3 and 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment outside Australia
Country [1] 3138 0
New Zealand
State/province [1] 3138 0

Funding & Sponsors
Funding source category [1] 258313 0
Commercial sector/Industry
Name [1] 258313 0
Mesynthes Limited
Country [1] 258313 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Mesynthes Limited
Address
69 Gracefield Road,
Lower Hutt, 5040
New Zealand
Country
New Zealand
Secondary sponsor category [1] 257478 0
None
Name [1] 257478 0
Address [1] 257478 0
Country [1] 257478 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32088 0
Address 32088 0
Country 32088 0
Phone 32088 0
Fax 32088 0
Email 32088 0
Contact person for public queries
Name 15335 0
Dr. Jeremy Simcock
Address 15335 0
Department of Plastic and Reconstructive Surgery
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch
New Zealand
Country 15335 0
New Zealand
Phone 15335 0
64 3 364-6660
Fax 15335 0
Email 15335 0
[email protected]
Contact person for scientific queries
Name 6263 0
Dr. Jeremy Simcock
Address 6263 0
Department of Plastic and Reconstructive Surgery
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch
New Zealand
Country 6263 0
New Zealand
Phone 6263 0
64 3 364-6660
Fax 6263 0
Email 6263 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.