NCT01895374

Brief Summary

Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

July 3, 2013

Last Update Submit

July 3, 2013

Conditions

Biological Dressings

Keywords

Laser therapyBiological dressingAmniotic membraneHydrocolloid bandageswound healing

Outcome Measures

Primary Outcomes (1)

  • Epithelization time

    time to complete epithelization after wounding

    2 weeks

Secondary Outcomes (6)

  • Epithelization Scale

    2 weeks

  • Photometric measurements

    2 weeks

  • Vancouver scar scale

    2 weeks

  • Assessment by subjects

    2 weeks

  • measurements of adverse effects

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

amniotic membrane dressing

EXPERIMENTAL

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

Procedure: laser treatmentsOther: amniotic membrane application

Hydrocolloid dressing

ACTIVE COMPARATOR

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

Procedure: laser treatmentsDevice: hydrocolloid application

Interventions

laser treatmentsPROCEDURE
Also known as: Laser ablation of the skin lesions
Hydrocolloid dressingamniotic membrane dressing
amniotic membrane applicationOTHER
Also known as: dressing with amniotic membrane
amniotic membrane dressing
hydrocolloid applicationDEVICE
Also known as: dressing with hydrocolloid as a comparator
Hydrocolloid dressing

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 20619656BACKGROUND

MeSH Terms

Interventions

Laser TherapyBandages

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, OperativeEquipment and Supplies

Study Officials

  • Dae Hun Suh, PhD

    Department of Dermatology, Seoul National University College of Medicine

    STUDY CHAIR

  • Seonguk Min, Msc

    Department of Dermatology, Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 10, 2013

Study Start

July 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

KR(1)