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

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04559165
• Collaborator: Police General Hospital (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 2.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer	Other: sericin and chitosan cream	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
• Anticipated Study Start Date: Sep 15, 2020
• Anticipated Primary Completion Date: May 16, 2021
• Anticipated Study Completion Date: Jun 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sericin and chitosan cream Apply sericin and chitosan cream on pressure ulcer 2 times/day for 21 days.	Other: sericin and chitosan cream; sericin and chitosan cream
Active Comparator: Cavilon cream Apply cavilon cream on pressure ulcer 2 times/day for 21 days.	Other: sericin and chitosan cream; sericin and chitosan cream

Outcome Measures

Primary Outcome Measures

1. Pressure ulcer scale for healing [21 days]

   Score 0 to 17, higher scores mean a worse outcome

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. Adverse events [21 days]

   Adverse events will be observed. They will be recorded as "present" or "not present"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity	Bangkok		Thailand	10310

Sponsors and Collaborators

• Chulalongkorn University
• Police General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT04559165
• Other Study ID Numbers: Dh09066063
• First Posted: Sep 22, 2020
• Last Update Posted: Sep 22, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pressure Ulcer; Chitosan

Study Results

No Results Posted as of Sep 22, 2020