NCT04559165

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

September 15, 2020

Last Update Submit

September 19, 2020

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • Pressure ulcer scale for healing

    Score 0 to 17, higher scores mean a worse outcome

    21 days

Secondary Outcomes (5)

  • Erythema index

    21 days

  • Melanin index

    21 days

  • Transepidermal water loss

    21 days

  • Moisture index

    21 days

  • Adverse events

    21 days

Study Arms (2)

sericin and chitosan cream

EXPERIMENTAL

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

Other: sericin and chitosan cream

Cavilon cream

ACTIVE COMPARATOR

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

Other: sericin and chitosan cream

Interventions

sericin and chitosan creamOTHER

sericin and chitosan cream

Cavilon creamsericin and chitosan cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 18 years old
  • 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

You may not qualify if:

  • Have uncontrolled diseases
  • Have complication or adverse effects during the time of participation
  • Cannot follow protocol
  • Pregnancy or lactation
  • Participate in other study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bangkok, 10310, Thailand

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Sericins

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SilkBiopolymersPolymersMacromolecular SubstancesArthropod ProteinsProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Pornanong Aramwit, Ph.D

CONTACT

+66899217255aramwit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 22, 2020

Study Start

September 15, 2020

Primary Completion

May 16, 2021

Study Completion

June 16, 2021

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

TH(1)