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NCT04559165 Clinical Trial

Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore

Pressure Ulcer Clinical Trial

Official title:
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04559165
Other study ID # Dh09066063
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date June 16, 2021

Study information
Verified date September 2020
Source Chulalongkorn University
Contact Pornanong Aramwit, Ph.D
Phone +66899217255
Email aramwit@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 16, 2021
Est. primary completion date May 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age more than 18 years old

- 2-digit Stirling Pressure Sore Severity Scale less than or equal to 2.4

- No chitosan, sericin, and dimethicone allergy

- Without skin diseases

- Without Autoimmune diseases

- Willingness to participate

Exclusion Criteria:

- Have uncontrolled diseases

- Have complication or adverse effects during the time of participation

- Cannot follow protocol

- Pregnancy or lactation

- Participate in other study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• sericin and chitosan cream
sericin and chitosan cream

Locations
Country Name City State
Thailand Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Chulalongkorn University Police General Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pressure ulcer scale for healing Score 0 to 17, higher scores mean a worse outcome 21 days
Secondary Erythema index Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. 21 days
Secondary Melanin index Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. 21 days
Secondary Transepidermal water loss Transepidermal water loss index of skin will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy skin. 21 days
Secondary Moisture index Moisture index of skin will be measured using Cutometer (Corneometer). There is no unit. Higher value mean lower risk of unhealthy skin. 21 days
Secondary Adverse events Adverse events will be observed. They will be recorded as "present" or "not present" 21 days
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