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Completed

NCT Number: NCT01413789

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

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).

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Key information

Conditions

Scar Tissue or Healthy Skin Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Dermatix

Drug

1 application of Dermatix

Kelocote

Drug

1 application of Kelocote

BAP scar gel

Drug

1 application of BAP scar gel

Alhydran

Drug

1 application of Alhydran

Bap Scar Care T

Drug

1 application of BAP Scar Care T

Bap Scar Care S

Drug

1 Application of Bap Scar Care S

Mepiform

Drug

1 application of Mepiform

Scar Ban Elastic

Drug

1 application of Scar Ban Elastic

Primary outcomes

  1. The occlusive and hydrating capacity of the products.

    Time frame: 1 hour after application

    Measurements will be done by using the TEWAmeter® for measurement of the Trans Epidermal Waterloss and the Corneometer® 825CM for measurement of the moisture content of the stratum corneum (Courage & Khazaka). For this study no risk factors are determined.

Secondary outcomes

  1. The occlusive and hydrating capacity of the products.

    Time frame: 2 hours after application

    Measurements will be done by using the TEWAmeter® for measurement of the Trans Epidermal Waterloss and the Corneometer® 825CM for measurement of the moisture content of the stratum corneum (Courage & Khazaka). For this study no risk factors are determined.

  2. The occlusive and hydrating capacity of the products.

    Time frame: 3 hours after application

    Measurements will be done by using the TEWAmeter® for measurement of the Trans Epidermal Waterloss and the Corneometer® 825CM for measurement of the moisture content of the stratum corneum (Courage & Khazaka). For this study no risk factors are determined.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels: BAP Scar Gel, Dermatix, Kelocote and One Gel- Cream: Alhydran

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2011
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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