Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04559165
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
Police General Hospital
Information provided by (Responsible Party):
Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : May 16, 2021
Estimated Study Completion Date : June 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
Drug Information available for: Poliglusam

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pressure ulcer scale for healing [ Time Frame: 21 days ]
    Score 0 to 17, higher scores mean a worse outcome


Secondary Outcome Measures :
  1. Erythema index [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 21 days ]
    Adverse events will be observed. They will be recorded as "present" or "not present"


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559165


Contacts
Layout table for location contacts
Contact: Pornanong Aramwit, Ph.D +66899217255 aramwit@gmail.com

Locations
Layout table for location information
Thailand
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity Recruiting
Bangkok, Thailand, 10310
Contact: Pornanong Aramwit, Ph.D.    +6689-921-7255    aramwit@gmail.com   
Principal Investigator: Pornanong Aramwit, Ph.D.         
Sponsors and Collaborators
Chulalongkorn University
Police General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT04559165    
Other Study ID Numbers: Dh09066063
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pressure Ulcer
Skin Ulcer
Skin Diseases
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants