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Trial History Detail on 2016-07-18

CUHK_CCRB00519

2016-07-18

Prospective

2015.544-T

China Regenerative Medicine International Limited

China Regenerative Medicine International Limited

N/A

Not Applicable

Dr Tor Chiu

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

26322639

torchiu@surgery.cuhk.edu.hk

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

Hong Kong

Dr sophia ko

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

26322639

sophiako@surgery.cuhk.edu.hk

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

Hong Kong

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

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

「安体肤」對深二度燒傷的功效:一項隨機對照試驗

Hong Kong

Yes

2016-03-31

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC ref no: 2015.544-T

Deep partial thickness burns

Other

Dressing material

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.

A sheet of Activskin applied topically

one layer of Activskin per area of burn wound

till wound healed

once off application

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

A sheet of paraffin gauze applied topically

one layer of paraffin gauze per area of burn wound

till wound healed

daily

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

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)

18

N/A

Both Male and Female

Interventional

Randomized

Allocation concealment: sealed envelope

Placebo

Single-blind

Trial subjects

Parallel

2

2016-08-01

64

Not Yet Recruiting

total healing time

Digital planimtery and clinical assessment

12months

scar assessment

mVSS and colour spectrophotometer

12months

No

2016-09-02

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