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

July 3, 2013 updated by: Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Department of Dermatology, Seoul National University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: amniotic membrane dressing
We compare the efficacy of amniotic membrane and hydrocolloid in same subjects to avoid confounders.
Procedure: laser treatments
Other Names:
  • Laser ablation of the skin lesions
Other: amniotic membrane application
Other Names:
  • dressing with amniotic membrane
ACTIVE_COMPARATOR: Hydrocolloid dressing
Same subjects received amniotic membrane and hydrocolloid dressing at the same time in different wound.
Procedure: laser treatments
Other Names:
  • Laser ablation of the skin lesions
Device: hydrocolloid application
Other Names:
  • dressing with hydrocolloid as a comparator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (ESTIMATE)

July 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012-0320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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