Clinical Efficacy of Bovine Freeze-dried Amniotic Membrane on Wound Healing in Laser Treatment

Study Overview
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Brief Summary
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Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.

Detailed Description
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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.

Official Title
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A Comparison of the Effects of Bovine Freeze-dried Amniotic Membrane and Hydrocolloid on Epithelialization After Laser Treatments

Conditions
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Biological Dressings

Intervention / Treatment
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* Procedure: laser treatments
* Other: amniotic membrane application
* Device: hydrocolloid application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Taking steroid or nonsteroidal antiinflammatory drug, isotretinoin underlying diabetes mellitus, keloid or any malignancy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amniotic membrane dressing<br>We compare the efficacy of amniotic membrane and hydrocolloid in same subjects to avoid confounders. | Procedure: laser treatments<br> <br> * Other names: Laser ablation of the skin lesions;Other: amniotic membrane application<br> <br> * Other names: dressing with amniotic membrane;|
| Active Comparator: Hydrocolloid dressing<br>Same subjects received amniotic membrane and hydrocolloid dressing at the same time in different wound. | Procedure: laser treatments<br> <br> * Other names: Laser ablation of the skin lesions;Device: hydrocolloid application<br> <br> * Other names: dressing with hydrocolloid as a comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelization time | time to complete epithelization after wounding | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelization Scale | Assessment of redness, oozing, swelling | 2 weeks | 
| Photometric measurements | spectrophotometer and colorimeter | 2 weeks | 
| Vancouver scar scale | Vancouver scar scale | 2 weeks | 
| Assessment by subjects | pain, itching, inconvenience | 2 weeks | 
| measurements of adverse effects | assessments of adverse effects by investigator | 2 weeks | 
| histopathologic analysis | changes of the tissue with time | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser therapy, Biological dressing, Amniotic membrane, Hydrocolloid bandages, wound healing