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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01413789
First received: August 8, 2011
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition Intervention
Scar Tissue or Healthy Skin
 Drug: Dermatix
Drug: Kelocote
Drug: BAP scar gel
Drug: Alhydran
Drug: Bap Scar Care T
Drug: Bap Scar Care S
Drug: Mepiform
Drug: Scar Ban Elastic

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels: BAP Scar Gel, Dermatix, Kelocote and One Gel- Cream: Alhydran

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • The occlusive and hydrating capacity of the products. [ Time Frame: 1 hour after application ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The occlusive and hydrating capacity of the products. [ Time Frame: 2 hours after application ] [ Designated as safety issue: No ]
    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.

  • The occlusive and hydrating capacity of the products. [ Time Frame: 3 hours after application ] [ Designated as safety issue: No ]
    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.


Enrollment: 55
Study Start Date: June 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
 Drug: Dermatix
1 application of Dermatix
Drug: Kelocote
1 application of Kelocote
Drug: BAP scar gel
1 application of BAP scar gel
Drug: Alhydran
1 application of Alhydran
Drug: Bap Scar Care T
1 application of BAP Scar Care T
Drug: Bap Scar Care S
1 Application of Bap Scar Care S
Drug: Mepiform
1 application of Mepiform
Drug: Scar Ban Elastic
1 application of Scar Ban Elastic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413789

Locations
Belgium
University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: S. Monstrey, MD PhD University Hospital, Ghent
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01413789     History of Changes
Other Study ID Numbers: 2011/350
Study First Received: August 8, 2011
Last Updated: April 15, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013