Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels and One Gel Cream

NCT ID: NCT01413789

Last Updated: 2013-04-16

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

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-07-31

Brief Summary

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Study hypothesis: Is Alhydran gel-cream as efficient as silicone gel for skin occlusion and hydration?

For this study 16 volunteers and ten patients with healed full thickness burns will be included.

After a short period of acclimatization four test areas will be determined. For healthy volunteers the standard zones are located on the inner forearm, two on each forearm.

For patients with healed burns the 4 test zones are located on either the healed donor site or the healed skin grafted area.

In each test zone baseline measurements will be taken before application of the products.After application of the three silicone gels and the hydrating gel cream the trans epidermal water loss (TEWL) and the moisture content of the stratum corneum will be measured by using the TEWAmeter®TM300 and the Corneometer® CM825 (Courage \& Khazaka).

Detailed Description

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Conditions

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Scar Tissue or Healthy Skin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients and healthy volunteers

Patients with healed full thickness burns and healthy volunteers will be included in the study

Group Type EXPERIMENTAL

Dermatix

Intervention Type DRUG

1 application of Dermatix

Kelocote

Intervention Type DRUG

1 application of Kelocote

BAP scar gel

Intervention Type DRUG

1 application of BAP scar gel

Alhydran

Intervention Type DRUG

1 application of Alhydran

Bap Scar Care T

Intervention Type DRUG

1 application of BAP Scar Care T

Bap Scar Care S

Intervention Type DRUG

1 Application of Bap Scar Care S

Mepiform

Intervention Type DRUG

1 application of Mepiform

Scar Ban Elastic

Intervention Type DRUG

1 application of Scar Ban Elastic

Interventions

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Dermatix

1 application of Dermatix

Intervention Type DRUG

Kelocote

1 application of Kelocote

Intervention Type DRUG

BAP scar gel

1 application of BAP scar gel

Intervention Type DRUG

Alhydran

1 application of Alhydran

Intervention Type DRUG

Bap Scar Care T

1 application of BAP Scar Care T

Intervention Type DRUG

Bap Scar Care S

1 Application of Bap Scar Care S

Intervention Type DRUG

Mepiform

1 application of Mepiform

Intervention Type DRUG

Scar Ban Elastic

1 application of Scar Ban Elastic

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers or patients with healed full thickness burns and donor sites
* not pregnant
* age\>18 years
* male or female
* written authorisation of the patient or volunteer is required.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S. Monstrey, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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2011/350

Identifier Type: -

Identifier Source: org_study_id

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