Disorder of Skin Donor SiteNCT04299126
Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound
A study testing high absorption pad for blood and pus and commercial wound dressing in people with Disorder of Skin Donor Site, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
High absorption pad for blood and pus with natural antimicrobial agent or gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras) will be randomly covered on half of split-thickness skin graft donor site wound. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Disorder of Skin Donor Site
- What is being tested?
- high absorption pad for blood and pus and commercial wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 5 Mar 2020to 15 Feb 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have split-thickness skin graft donor site wound on thigh
- Age 18-60 years
- Can read and write
- Can follow the study protocol
- Available on appointment date
Who cannot join
- Systemic infection
- Chronic skin diseases
- Immune deficiency
- Allergic to cellulose, chitosan, sericin, and chlorhexidine
- Psychotic disorders
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Bangkok, 10310
About this study
Official title: Efficacy and Safety of High Absorption Pad for Blood and Pus With Natural Antimicrobial Agent in Split-thickness Skin Graft Donor Site Wound
High absorption pad for blood and pus with natural antimicrobial agent or gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras) will be randomly covered on half of split-thickness skin graft donor site wound. The another will be cover on another half of split-thickness skin graft donor site wound. Then, they will be covered with gauzes and bandage. Time to wound healing, amounts of covered dressing gauzes, signs of infection, pain score, erythema index, melanin index, trans epidermal water loss index, and adverse events will be evaluated.
- Conditions
- Disorder of Skin Donor Site
- Being tested
- high absorption pad for blood and pus, commercial wound dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high absorption pad for blood and pusDevice
High absorption pad for blood and pus will be covered on half of split-thickness skin graft donor site wound until the wound has healed.
commercial wound dressingDevice
Commercial wound dressing will be covered on half of split-thickness skin graft donor site wound until the wound has healed.
| Study group | Role | What they receive |
|---|---|---|
| high absorption pad for blood and pus | Experimental | High absorption pad for blood and pus with natural antimicrobial agent composes of sericin and chitosan. It will be covered on half of split-thickness skin graft donor site wound until the wound has healed. Receives: Device: high absorption pad for blood and pus |
| commercial wound dressing | Active comparator | Commercial wound dressing is gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras). It will be covered on half of split-thickness skin graft donor site wound until the wound has healed. Receives: Device: commercial wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing time
The day that the dressing will detach without painful.
Measured: not more than 28 days
amounts of secondary gauze dressing
The amounts of secondary gauze dressing that will be changed because of blood over capacity.
Measured: not more than 28 days
Secondary outcomes (11)
pain score
Pain score will be evaluated using visual analogue scale. The 0 and 10 scores mean no pain and very pain, respectively. Higher score means more painful.
Measured: 5 days after donor site wound was created
signs of infection
Signs of infection mean pain, swollen, red, and warn including pus on the wound.
Measured: not more than 28 days
scar melanin index
Scar melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Measured: 3 months
scar erythema index
Scar erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Measured: 3 months
transepidermal water loss index
Transepidermal water loss index of scar will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy scar.
Measured: 3 months
scar quality
Scar quality will be evaluated using vancouver scar scale. The 0 and 13 scores mean high scar quality and low scar quality , respectively. Higher score means low scar quality.
Measured: 3 months
adverse events
Adverse events will be observed. They will be recorded as "present" or "not present".
Measured: not more than 28 days
aspartate aminotransferase in serum
Aspartate aminotransferase in serum (in U/L) after treatment will not be more than before treatment.
Measured: not more than 28 days
alanine aminotransferase in serum
Alanine aminotransferase in serum (in U/L) after treatment will not be more than before treatment.
Measured: not more than 28 days
blood urea nitrogen
Blood urea nitrogen (in mg/dl) after treatment will not be more than before treatment.
Measured: not more than 28 days
serum creatinine
Serum creatinine (in mg/dl) after treatment will not be more than before treatment.
Measured: not more than 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start5 Mar 2020 (estimated)
- Primary completion30 Jan 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Skin Donor SiteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299126
- Sponsor's protocol ID
- 625/62
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of High Absorption Pad for Blood and Pus With Natural Antimicrobial Agent in Split-thickness Skin Graft Donor Site Wound
- ClinicalTrials.gov ID
- NCT04299126
- Acronym / sponsor ID
- 625/62
- Conditions
- Disorder of Skin Donor Site
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 5 Mar 2020 (estimated)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 6 Mar 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.
High absorption pad for blood and pus with natural antimicrobial agent or gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras) will be randomly covered on half of split-thickness skin graft donor site wound. The another will be cover on another half of split-thickness skin graft donor site wound. Then, they will be covered with gauzes and bandage. Time to wound healing, amounts of covered dressing gauzes, signs of infection, pain score, erythema index, melanin index, trans epidermal water loss index, and adverse events will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high absorption pad for blood and pus | Experimental | Device: high absorption pad for blood and pusHigh absorption pad for blood and pus with natural antimicrobial agent composes of sericin and chitosan. It will be covered on half of split-thickness skin graft donor site wound until the wound has healed. |
| commercial wound dressing | Active comparator | Device: commercial wound dressingCommercial wound dressing is gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras). It will be covered on half of split-thickness skin graft donor site wound until the wound has healed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have split-thickness skin graft donor site wound on thigh
- Age 18-60 years
- Can read and write
- Can follow the study protocol
- Available on appointment date
Key exclusion criteria (6 listed)
- Systemic infection
- Chronic skin diseases
- Immune deficiency
- Allergic to cellulose, chitosan, sericin, and chlorhexidine
- Psychotic disorders
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 |
|---|---|---|
| high absorption pad for blood and pusHigh absorption pad for blood and pus will be covered on half of split-thickness skin graft donor site wound until the wound has healed. | Device | high absorption pad for blood and pus |
| commercial wound dressingCommercial wound dressing will be covered on half of split-thickness skin graft donor site wound until the wound has healed. | Device | commercial wound dressing |
Primary outcome
wound healing time
Time frame: not more than 28 days
The day that the dressing will detach without painful.
amounts of secondary gauze dressing
Time frame: not more than 28 days
The amounts of secondary gauze dressing that will be changed because of blood over capacity.
11 secondary outcomes
pain score
Time frame: 5 days after donor site wound was created
signs of infection
Time frame: not more than 28 days
scar melanin index
Time frame: 3 months
scar erythema index
Time frame: 3 months
transepidermal water loss index
Time frame: 3 months
scar quality
Time frame: 3 months
adverse events
Time frame: not more than 28 days
aspartate aminotransferase in serum
Time frame: not more than 28 days
alanine aminotransferase in serum
Time frame: not more than 28 days
blood urea nitrogen
Time frame: not more than 28 days
serum creatinine
Time frame: not more than 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
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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 high absorption pad for blood and pus and commercial wound dressing in people with Disorder of Skin Donor Site, 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 5 inclusion and 6 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 6 Mar 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?
wound healing time (time frame: not more than 28 days). The study lists 2 primary outcomes in all. 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 6 Mar 2020.