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

Not Applicable

Completed

• Conditions: Scar Tissue or Healthy Skin
• Interventions: 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

• Registration Number: NCT01413789
• Lead Sponsor: University Hospital, Ghent

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients and healthy volunteers	Bap Scar Care S	Patients with healed full thickness burns and healthy volunteers will be included in the study
Patients and healthy volunteers	Dermatix	Patients with healed full thickness burns and healthy volunteers will be included in the study
Patients and healthy volunteers	Kelocote	Patients with healed full thickness burns and healthy volunteers will be included in the study
Patients and healthy volunteers	BAP scar gel	Patients with healed full thickness burns and healthy volunteers will be included in the study
Patients and healthy volunteers	Alhydran	Patients with healed full thickness burns and healthy volunteers will be included in the study
Patients and healthy volunteers	Bap Scar Care T	Patients with healed full thickness burns and healthy volunteers will be included in the study
Patients and healthy volunteers	Mepiform	Patients with healed full thickness burns and healthy volunteers will be included in the study
Patients and healthy volunteers	Scar Ban Elastic	Patients with healed full thickness burns and healthy volunteers will be included in the study

Primary Outcome Measures

Name	Time	Method
The occlusive and hydrating capacity of the products.	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 Outcome Measures

Name	Time	Method
The occlusive and hydrating capacity of the products.	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.

Trial Locations

Locations (1)

University Hospital; 🇧🇪 Ghent, Belgium