Trial Outcomes & Findings for Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment (NCT NCT01539980)

NCT ID: NCT01539980

Last Updated: 2015-04-02

Results Overview

Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: Within 14 days after operation
• Results posted on: 2015-04-02

Participant Flow

Participant milestones

Measure	Sericin Scaffold Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment

Baseline characteristics by cohort

Measure	Sericin Scaffold n=30 Participants Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Region of Enrollment Thailand	30 participants n=93 Participants
Wound size	124.74 square centrimeter STANDARD_DEVIATION 86.72 • n=93 Participants
Body temperature	36.73 Degree celcius STANDARD_DEVIATION 0.37 • n=93 Participants

PRIMARY outcome

Timeframe: Within 14 days after operation

Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.

Outcome measures

Measure	Sericin Scaffold n=30 Participants Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site
Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment	12 Days Standard Deviation 5

SECONDARY outcome

Timeframe: Within 14 days after operation

Number of patients with infected wound

Outcome measures

Measure	Sericin Scaffold n=30 Participants Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site
Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment	0 Number of patients with infected wound

SECONDARY outcome

Timeframe: Within 14 days after operation

Pain may occur on operation wounds. Visual analog scale is used by patients themselves for monitoring the pain level with 0 = no pain, 10 = worst possible pain.

Outcome measures

Measure	Sericin Scaffold n=30 Participants Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site
Pain Levels of Wounds	2.60 units on a scale Standard Deviation 1.40

SECONDARY outcome

Timeframe: Within 14 days after operation

The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used.

Outcome measures

Measure	Sericin Scaffold n=30 Participants Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site
Proinflammatory Cytokines (IL)	31.65 pg/mL Standard Deviation 16.71

SECONDARY outcome

Timeframe: Within 14 days after operation

Large, open wound may absorb some materials from wound dressing. If those materials are toxic, liver enzyme (a major organ for elimination of any toxicities) will be increased.

Outcome measures

Measure	Sericin Scaffold n=30 Participants Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site
Liver Enzyme (AST)	19 u/L Standard Deviation 10

Adverse Events

Sericin Scaffold

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Sericin Scaffold n=30 participants at risk Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site

Skin and subcutaneous tissue disorders Itching

6.7% 2/30 • Number of events 2

Additional Information

Professor Pornanong Aramwit, Pharm.D., Ph.D.

Faculty of Pharmaceutical Sciences, Chulalongkorn University

Phone: +66899217255

Email: aramwit@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place