Pressure UlcerNCT04559165
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
A study testing sericin and chitosan cream in people with Pressure Ulcer, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- sericin and chitosan cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 15 Sep 2020to 16 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have uncontrolled diseases
- Have complication or adverse effects during the time of participation
- Cannot follow protocol
- Pregnancy or lactation
- Participate in other study
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Bangkok, 10310
Pornanong Aramwit, Ph.D., +6689-921-7255, aramwit@gmail.com
Pornanong Aramwit, Ph.D.
About this study
To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients
- Conditions
- Pressure Ulcer
- Being tested
- sericin and chitosan cream
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sericin and chitosan creamOther
sericin and chitosan cream
| Study group | Role | What they receive |
|---|---|---|
| sericin and chitosan cream | Experimental | Apply sericin and chitosan cream on pressure ulcer 2 times/day for 21 days. Receives: Other: sericin and chitosan cream |
| Cavilon cream | Active comparator | Apply cavilon cream on pressure ulcer 2 times/day for 21 days. Receives: Other: sericin and chitosan cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer scale for healing
Score 0 to 17, higher scores mean a worse outcome
Measured: 21 days
Secondary outcomes (5)
Erythema index
Erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Measured: 21 days
Melanin index
Melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Measured: 21 days
Transepidermal water loss
Transepidermal water loss index of skin will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy skin.
Measured: 21 days
Moisture index
Moisture index of skin will be measured using Cutometer (Corneometer). There is no unit. Higher value mean lower risk of unhealthy skin.
Measured: 21 days
Adverse events
Adverse events will be observed. They will be recorded as "present" or "not present"
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start15 Sep 2020 (estimated)
- Primary completion16 May 2021 (estimated)
- Study completion16 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Police General Hospital
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559165
- Sponsor's protocol ID
- Dh09066063
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
- ClinicalTrials.gov ID
- NCT04559165
- Acronym / sponsor ID
- Dh09066063
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Police General Hospital
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 16 May 2021 (estimated)
- Study completion
- 16 Jun 2021 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sericin and chitosan cream | Experimental | Other: sericin and chitosan creamApply sericin and chitosan cream on pressure ulcer 2 times/day for 21 days. |
| Cavilon cream | Active comparator | Other: sericin and chitosan creamApply cavilon cream on pressure ulcer 2 times/day for 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Have uncontrolled diseases
- Have complication or adverse effects during the time of participation
- Cannot follow protocol
- Pregnancy or lactation
- Participate in other study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sericin and chitosan creamsericin and chitosan cream | Other | Cavilon cream, sericin and chitosan cream |
Primary outcome
Pressure ulcer scale for healing
Time frame: 21 days
Score 0 to 17, higher scores mean a worse outcome
5 secondary outcomes
Erythema index
Time frame: 21 days
Melanin index
Time frame: 21 days
Transepidermal water loss
Time frame: 21 days
Moisture index
Time frame: 21 days
Adverse events
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
Related trials for Pressure Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sericin and chitosan cream in people with Pressure Ulcer, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pornanong Aramwit, Ph.D (+66899217255, aramwit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure ulcer scale for healing (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.