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

September 19, 2020 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10310
        • Recruiting
        • Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
        • Contact:
        • Principal Investigator:
          • Pornanong Aramwit, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure ulcer scale for healing
Time Frame: 21 days
Score 0 to 17, higher scores mean a worse outcome
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21 days
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.
21 days
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.
21 days
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.
21 days
Adverse events
Time Frame: 21 days
Adverse events will be observed. They will be recorded as "present" or "not present"
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

Police General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2020

Primary Completion (Anticipated)

May 16, 2021

Study Completion (Anticipated)

June 16, 2021

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 19, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 19, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dh09066063

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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