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

Not Applicable

• Conditions: Pressure Ulcer
• Interventions: Other: sericin and chitosan cream

• Registration Number: NCT04559165
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-15
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-19
• Last Update Submitted: 2020-09-19
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22
• Primary Completion: 2021-05-16
• Study Completion: 2021-06-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sericin and chitosan cream	sericin and chitosan cream	Apply sericin and chitosan cream on pressure ulcer 2 times/day for 21 days.
Cavilon cream	sericin and chitosan cream	Apply cavilon cream on pressure ulcer 2 times/day for 21 days.

Primary Outcome Measures

Name	Time	Method
Pressure ulcer scale for healing	21 days	Score 0 to 17, higher scores mean a worse outcome

Secondary Outcome Measures

Name	Time	Method
Adverse events	21 days	Adverse events will be observed. They will be recorded as "present" or "not present"
Erythema index	21 days	Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Melanin index	21 days	Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Transepidermal water loss	21 days	Transepidermal water loss index of skin will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy skin.
Moisture index	21 days	Moisture index of skin will be measured using Cutometer (Corneometer). There is no unit. Higher value mean lower risk of unhealthy skin.

Trial Locations

Locations (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity; 🇹🇭 Bangkok, Thailand