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

NCT ID: NCT04559165

Last Updated: 2020-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-06-16

Brief Summary

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

Detailed Description

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Conditions

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Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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sericin and chitosan cream

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

Group Type EXPERIMENTAL

sericin and chitosan cream

Intervention Type OTHER

sericin and chitosan cream

Cavilon cream

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

Group Type ACTIVE_COMPARATOR

sericin and chitosan cream

Intervention Type OTHER

sericin and chitosan cream

Interventions

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sericin and chitosan cream

sericin and chitosan cream

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Police General Hospital

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Pornanong Aramwit, Ph.D

Role: CONTACT

+66899217255

Facility Contacts

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Pornanong Aramwit, Ph.D.

Role: primary

+6689-921-7255

Other Identifiers

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Dh09066063

Identifier Type: -

Identifier Source: org_study_id

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