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

NCT ID: NCT01895374

Last Updated: 2013-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-05-31

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.

Conditions

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Biological Dressings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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amniotic membrane dressing

We compare the efficacy of amniotic membrane and hydrocolloid in same subjects to avoid confounders.

Group Type EXPERIMENTAL

laser treatments

Intervention Type PROCEDURE

amniotic membrane application

Intervention Type OTHER

Hydrocolloid dressing

Same subjects received amniotic membrane and hydrocolloid dressing at the same time in different wound.

Group Type ACTIVE_COMPARATOR

laser treatments

Intervention Type PROCEDURE

hydrocolloid application

Intervention Type DEVICE

Interventions

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laser treatments

Intervention Type PROCEDURE

amniotic membrane application

Intervention Type OTHER

hydrocolloid application

Intervention Type DEVICE

Other Intervention Names

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Laser ablation of the skin lesions dressing with amniotic membrane dressing with hydrocolloid as a comparator

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dae Hun Suh, PhD

Role: STUDY_CHAIR

Department of Dermatology, Seoul National University College of Medicine

Seonguk Min, Msc

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Seoul National University College of Medicine

Locations

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Department of Dermatology, Seoul National University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 20619656 (View on PubMed)

Other Identifiers

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2012-0320

Identifier Type: -

Identifier Source: org_study_id

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