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

Not Applicable

Completed

• Conditions: Biological Dressings
• Interventions: Procedure: laser treatments; Other: amniotic membrane application; Device: hydrocolloid application

• Registration Number: NCT01895374
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-07
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-03
• Last Update Submitted: 2013-07-03
• Study First Posted: 2013-07-10
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

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Exclusion Criteria

• Taking steroid or nonsteroidal antiinflammatory drug, isotretinoin
• underlying diabetes mellitus, keloid or any malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
amniotic membrane dressing	amniotic membrane application	We compare the efficacy of amniotic membrane and hydrocolloid in same subjects to avoid confounders.
amniotic membrane dressing	laser treatments	We compare the efficacy of amniotic membrane and hydrocolloid in same subjects to avoid confounders.
Hydrocolloid dressing	laser treatments	Same subjects received amniotic membrane and hydrocolloid dressing at the same time in different wound.
Hydrocolloid dressing	hydrocolloid application	Same subjects received amniotic membrane and hydrocolloid dressing at the same time in different wound.

Primary Outcome Measures

Name	Time	Method
Epithelization time	2 weeks	time to complete epithelization after wounding

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Dermatology, Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of