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

Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Scar Tissue or Healthy Skin

Intervention: 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 (Drug)

Phase: N/A

Status: Completed

Sponsored by: University Hospital, Ghent

Official(s) and/or principal investigator(s):
S. Monstrey, MD PhD, Principal Investigator, Affiliation: University Hospital, Ghent

Summary

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).

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The occlusive and hydrating capacity of the products.

Secondary outcome:

The occlusive and hydrating capacity of the products.

The occlusive and hydrating capacity of the products.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

-

Locations and Contacts

University Hospital, Ghent 9000, Belgium
Additional Information

Starting date: June 2011
Last updated: April 15, 2013

Page last updated: August 20, 2015

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