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

NCT01413789 | Completed

• 1 other identifier: 2011/350
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Scar Tissue or Healthy Skin

Outcome Measures

Primary Outcomes (1)

• The occlusive and hydrating capacity of the products.

  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.

  1 hour after application

Secondary Outcomes (2)

• The occlusive and hydrating capacity of the products.

  2 hours after application

• The occlusive and hydrating capacity of the products.

  3 hours after application

Study Arms (1)

Patients and healthy volunteers

EXPERIMENTAL

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

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

Interventions

Dermatix DRUG

1 application of Dermatix

Patients and healthy volunteers

Kelocote DRUG

1 application of Kelocote

Patients and healthy volunteers

BAP scar gel DRUG

1 application of BAP scar gel

Patients and healthy volunteers

Alhydran DRUG

1 application of Alhydran

Patients and healthy volunteers

Bap Scar Care T DRUG

1 application of BAP Scar Care T

Patients and healthy volunteers

Bap Scar Care S DRUG

1 Application of Bap Scar Care S

Patients and healthy volunteers

Mepiform DRUG

1 application of Mepiform

Patients and healthy volunteers

Scar Ban Elastic DRUG

1 application of Scar Ban Elastic

Patients and healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• S. Monstrey, MD PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 10, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 16, 2013

Record last verified: 2013-04

Locations

BE (1)