Subdermal implantation of the collagen-elastin-matrix Matriderm® to improve profile and skin structure of degenerative changes in the midface region [Subkutaner einsatz der kollagen-elastin-matrix Matriderm® zur verbesserung von profil und hautstruktur bei degenerativen veränderungen des mittelgesichtes]
| ISRCTN | ISRCTN35051281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35051281 |
| Secondary identifying numbers | DE/CA22/2-2008/KLP |
- Submission date
- 15/05/2009
- Registration date
- 31/07/2009
- Last edited
- 31/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Henrik Menke
Scientific
Scientific
Klinik für Plastische-, Ästhetische- und Handchirurgie
Schwerbrandverletztenzentrum
Starkenburgring 66
Offenbach
63069
Germany
Study information
| Study design | Non-randomised single-arm clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Subdermal implantation of the collagen-elastin-matrix Matriderm® to improve profile and skin structure of degenerative changes in the midface region: a non-randomised single arm clinical trial |
| Study acronym | SIMAMID II |
| Study objectives | Collagen matrices are in clinical use in plastic and burn surgery under split skin for dermal regeneration; in this study we investigate the effects of subdermal implantation of the matrix under healthy skin on mid-face profile, skin quality and dermal architecture. |
| Ethics approval(s) | The local ethics committee (Ethik-Kommission bei der Landesärztekammer Hessen) approved on the 4th June 2008 (ref: FF 29/2008) |
| Health condition(s) or problem(s) studied | Degenerative structure of profile and/or skin quality in the mid-face, caused by disease or ageing |
| Intervention | Step 1: Subdermal laminar implantation of a collagen-elastin-matrix on the upper arm Step 2: Subdermal laminar implantation of a collagen-elastin-matrix on the mid-face region Skin biopsies (upper arm) before, 6 and 12 months post-operatively. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Matriderm® |
| Primary outcome measure | Clinical outcome of mid-face region, measured at month 8 after step 1 (upper arm). |
| Secondary outcome measures | Clinical, histological and cutometric outcome upper arm, measured at month 14 after step 1 (upper arm). |
| Overall study start date | 15/05/2008 |
| Completion date | 14/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | Healthy adults aged 40 - 65 years, either sex |
| Key exclusion criteria | 1. Severe allergies 2. Severe acute or chronic diseases 3. Skin infections |
| Date of first enrolment | 15/05/2008 |
| Date of final enrolment | 14/11/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik für Plastische-, Ästhetische- und Handchirurgie
Offenbach
63069
Germany
63069
Germany
Sponsor information
Dr Suwelack Skin and Health Care AG (Germany)
Industry
Industry
Josef-Suwelack-Strasse
Billerbeck
48727
Germany
"ROR" |
https://ror.org/05hqyp882 |
|---|
Funders
Funder type
Industry
Dr Suwelack Skin and Health Care AG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
