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

Primary Purpose

Pressure Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
sericin and chitosan cream
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn UnviersityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sericin and chitosan cream

Cavilon cream

Arm Description

Apply sericin and chitosan cream on pressure ulcer 2 times/day for 21 days.

Apply cavilon cream on pressure ulcer 2 times/day for 21 days.

Outcomes

Primary Outcome Measures

Pressure ulcer scale for healing
Score 0 to 17, higher scores mean a worse outcome

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2020
Last Updated
September 19, 2020
Sponsor
Chulalongkorn University
Collaborators
Police General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04559165
Brief Title
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
Official Title
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2020 (Anticipated)
Primary Completion Date
May 16, 2021 (Anticipated)
Study Completion Date
June 16, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
Police General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sericin and chitosan cream
Arm Type
Experimental
Arm Description
Apply sericin and chitosan cream on pressure ulcer 2 times/day for 21 days.
Arm Title
Cavilon cream
Arm Type
Active Comparator
Arm Description
Apply cavilon cream on pressure ulcer 2 times/day for 21 days.
Intervention Type
Other
Intervention Name(s)
sericin and chitosan cream
Intervention Description
sericin and chitosan cream
Primary Outcome Measure Information:
Title
Pressure ulcer scale for healing
Description
Score 0 to 17, higher scores mean a worse outcome
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Erythema index
Description
Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Time Frame
21 days
Title
Melanin index
Description
Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Time Frame
21 days
Title
Transepidermal water loss
Description
Transepidermal water loss index of skin will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy skin.
Time Frame
21 days
Title
Moisture index
Description
Moisture index of skin will be measured using Cutometer (Corneometer). There is no unit. Higher value mean lower risk of unhealthy skin.
Time Frame
21 days
Title
Adverse events
Description
Adverse events will be observed. They will be recorded as "present" or "not present"
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pornanong Aramwit, Ph.D
Phone
+66899217255
Email
aramwit@gmail.com
Facility Information:
Facility Name
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
City
Bangkok
ZIP/Postal Code
10310
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D.
Phone
+6689-921-7255
Email
aramwit@gmail.com
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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