Biological DressingsNCT01895374
Clinical Efficacy of Bovine Freeze-dried Amniotic Membrane on Wound Healing in Laser Treatment
A study testing laser treatments, amniotic membrane application and hydrocolloid application in people with Biological Dressings, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Bovine amniotic membrane may show better efficacy than hydrocolloid dressing. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Dressings
- What is being tested?
- laser treatments, amniotic membrane application and hydrocolloid application
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to May 2013
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Skin lesions treatable by ablative lasers
- More than two skin lesions of similar size at the same area
- Available during the study period (2 weeks)
Who cannot join
- Taking steroid or nonsteroidal antiinflammatory drug, isotretinoin
- underlying diabetes mellitus, keloid or any malignancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Dermatology, Seoul National University College of Medicine
Seoul, 110-744
About this study
Official title: A Comparison of the Effects of Bovine Freeze-dried Amniotic Membrane and Hydrocolloid on Epithelialization After Laser Treatments
Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.
Read the detailed description
Bovine amniotic membrane as a biological dressing can be applicable to wound after laser treatments. Comparing with hydrocolloid dressing material, which is the most widely used after laser treatment now, amniotic membrane will show better efficacy. Thus, with amniotic membrane, epithelization time will shorten and redness which is usually left after laser will disappear quickly.
- Conditions
- Biological Dressings
- Being tested
- laser treatments, amniotic membrane application, hydrocolloid application
- Keywords
- Laser therapy, Biological dressing, Amniotic membrane, Hydrocolloid bandages, wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser treatmentsProcedure or surgery
Also called Laser ablation of the skin lesions
amniotic membrane applicationOther
Also called dressing with amniotic membrane
hydrocolloid applicationDevice
Also called dressing with hydrocolloid as a comparator
| Study group | Role | What they receive |
|---|---|---|
| amniotic membrane dressing | Experimental | We compare the efficacy of amniotic membrane and hydrocolloid in same subjects to avoid confounders. Receives: Procedure: laser treatments; Other: amniotic membrane application |
| Hydrocolloid dressing | Active comparator | Same subjects received amniotic membrane and hydrocolloid dressing at the same time in different wound. Receives: Procedure: laser treatments; Device: hydrocolloid application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelization time
time to complete epithelization after wounding
Measured: 2 weeks
Secondary outcomes (6)
Epithelization Scale
Assessment of redness, oozing, swelling
Measured: 2 weeks
Photometric measurements
spectrophotometer and colorimeter
Measured: 2 weeks
Vancouver scar scale
Vancouver scar scale
Measured: 2 weeks
Assessment by subjects
pain, itching, inconvenience
Measured: 2 weeks
measurements of adverse effects
assessments of adverse effects by investigator
Measured: 2 weeks
histopathologic analysis
changes of the tissue with time
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biological DressingsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dae Hun Suh, PhD, Study chair, Department of Dermatology, Seoul National University College of MedicineSeonguk Min, Msc, Principal investigator, Department of Dermatology, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895374
- Sponsor's protocol ID
- 2012-0320
- Status last verified
- Jul 2013
- First submitted
- 3 Jul 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Singh R, Chacharkar MP. Dried gamma-irradiated amniotic membrane as dressing in burn wound care. J Tissue Viability. 2011 May;20(2):49-54. doi: 10.1016/j.jtv.2010.06.001. Epub 2010 Jul 8.
PubMed 20619656
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Bovine Freeze-dried Amniotic Membrane and Hydrocolloid on Epithelialization After Laser Treatments
- ClinicalTrials.gov ID
- NCT01895374
- Acronym / sponsor ID
- 2012-0320
- Conditions
- Biological Dressings
- Keywords
- Laser therapy, Biological dressing, Amniotic membrane, Hydrocolloid bandages, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Jul 2013 (estimated)
- 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.
Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.
Detailed description
Bovine amniotic membrane as a biological dressing can be applicable to wound after laser treatments. Comparing with hydrocolloid dressing material, which is the most widely used after laser treatment now, amniotic membrane will show better efficacy. Thus, with amniotic membrane, epithelization time will shorten and redness which is usually left after laser will disappear quickly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amniotic membrane dressing | Experimental | Procedure: laser treatments, Other: amniotic membrane applicationWe compare the efficacy of amniotic membrane and hydrocolloid in same subjects to avoid confounders. |
| Hydrocolloid dressing | Active comparator | Procedure: laser treatments, Device: hydrocolloid applicationSame subjects received amniotic membrane and hydrocolloid dressing at the same time in different wound. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Skin lesions treatable by ablative lasers
- More than two skin lesions of similar size at the same area
- Available during the study period (2 weeks)
Key exclusion criteria (2 listed)
- Taking steroid or nonsteroidal antiinflammatory drug, isotretinoin
- underlying diabetes mellitus, keloid or any malignancy
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 |
|---|---|---|
| laser treatmentsAlso: Laser ablation of the skin lesions | Procedure or surgery | Hydrocolloid dressing, amniotic membrane dressing |
| amniotic membrane applicationAlso: dressing with amniotic membrane | Other | amniotic membrane dressing |
| hydrocolloid applicationAlso: dressing with hydrocolloid as a comparator | Device | Hydrocolloid dressing |
Primary outcome
Epithelization time
Time frame: 2 weeks
time to complete epithelization after wounding
6 secondary outcomes
Epithelization Scale
Time frame: 2 weeks
Photometric measurements
Time frame: 2 weeks
Vancouver scar scale
Time frame: 2 weeks
Assessment by subjects
Time frame: 2 weeks
measurements of adverse effects
Time frame: 2 weeks
histopathologic analysis
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
- Background: PubMed 20619656Singh R, Chacharkar MP. Dried gamma-irradiated amniotic membrane as dressing in burn wound care. J Tissue Viability. 2011 May;20(2):49-54. doi: 10.1016/j.jtv.2010.06.001. Epub 2010 Jul 8.
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.
Dae Hun Suh, PhD study chair
Department of Dermatology, Seoul National University College of Medicine
Seonguk Min, Msc principal investigator
Department of Dermatology, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser treatments, amniotic membrane application and hydrocolloid application in people with Biological Dressings, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jul 2013. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epithelization time (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01895374, which also lists 1 linked publication.
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 10 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.