Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00519

2 Trial Registration Date

2016-07-18

i Registration Status

Prospective

3 Secondary IDs

2015.544-T

4 Source(s) of Funding

China Regenerative Medicine International Limited

5 Primary Sponsor

China Regenerative Medicine International Limited

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr Tor Chiu

ii Address

Division of Plastic, Reconstructive and Aesthetic Surgery, Department of Surgery, Prince of Wales Hospital
30-32 Ngan Shing Street, Shatin, NT

iii Phone

26322639

iv Email

torchiu@surgery.cuhk.edu.hk

v Affiliation

Division of Plastic, Reconstructive and Aesthetic Surgery, Department of Surgery, Prince of Wales Hospital

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr sophia ko

ii Address

Division of Plastic, Reconstructive and Aesthetic Surgery, Department of Surgery, Prince of Wales Hospital
30-32 Ngan Shing Street, Shatin, NT

iii Phone

26322639

iv Email

sophiako@surgery.cuhk.edu.hk

v Affiliation

Division of Plastic, Reconstructive and Aesthetic Surgery, Department of Surgery, Prince of Wales Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

The effect of Activskin on deep partial thickness burns: a randomised control trial

10 Public Title

The effect of Activskin on deep partial thickness burns: a randomised control trial

i Public Title in Chinese 研究名稱

「安体肤」對深二度燒傷的功效：一項隨機對照試驗

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-03-31

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC ref no: 2015.544-T

14 Medical Condition Being Studied

Deep partial thickness burns

15 Intervention

i Types of intervention

Other

Please specify

Dressing material

ii Description/ name of Intervention/article

ActivSkin is a tissue engineered synthetic skin substitute that is composed of two layers: an outer layer composed of human epithelial cells and a inner layer with bovine collagen and human fibroblasts that produce components of ECM. Prior studies have shown that Activskin can accelerate wound healing in burns and ulcer wounds. The product received CFDA approval in 2014 (no. 3460614). It would fall under the category of a class IV Medical Device in Hong Kong.

iii Dosage form of the intervention

A sheet of Activskin applied topically

iv Dosage of the intervention

one layer of Activskin per area of burn wound

v Duration of the intervention

till wound healed

vi Frequency of the intervention

once off application

16 Comparative Treatments

i Description/ name of comparative treatments

standard dressing: normal saline cleansing and burns dressings, and paraffin gauze

ii Dosage form of the comparative treatments

A sheet of paraffin gauze applied topically

iii Dosage of the comparative treatments

one layer of paraffin gauze per area of burn wound

iv Duration of the comparative treatments

till wound healed

v Frequency of the comparative treatments

daily

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

All patients  18 years old with two or more areas of deep partial thickness burns as defined by the LDI scanner

Patient consents to having clinical photos taken

Informed consent available

ii Exclusion Criteria

Patients who are unable to consent

Infected wounds

Allergy to bovine collagen

Delayed presentation

Pregnancy

Potential patient non-compliance (refusing to follow schedule of events/follow ups)

iii Age Minimum

18

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Allocation concealment: sealed envelope

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-08-01

21 Target Sample Size

64

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

total healing time

ii The metric or method of measurement used

Digital planimtery and clinical assessment

iii The timepoint(s) of primary interest

12months

24 Secondary Outcome

i The Name of the outcome

scar assessment

ii The metric or method of measurement used

mVSS and colour spectrophotometer

iii The timepoint(s) of primary interest

12months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-09-02

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-07-18