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Application of cultured autologous keratinocytes in combination with a meshed split skin autograft for burn wound healing

Application of cultured autologous keratinocytes in combination with a meshed split skin autograft for burn wound healing - Cultured keratinocytes for burn wound treatment

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35395
Enrollment
50
Registered
2007-08-02
Start date
2008-06-27
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

deep (third degree) burn wounds

Interventions

Within the first few day after admission to the burn centre a biopsy (approx. 3 cm2) is taken from the unaffected skin and taken to the lab for the culture of the keratinocytes. After two weeks the

Sponsors

Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -competent and temporarily incompetent patients 18 years of age or older with acute burn wounds that require widely meshed skin grafting, which do not need immediate excision - minimal study wound area 100 cm2 - maximal study wound area 300 cm2 - maximal TBSA 50% full thickness wounds -Informed consent

Exclusion criteria

Exclusion criteria: - Immunocompromised patients - Infected wounds - Use of high doses of (.20mg/pd) corticosteroids and/or cytostatica - Known penicillin allergy - Conditions where the patient is non compliant as judged by a medical specialist

Design outcomes

Primary

MeasureTime frame
The % of wound closure after 7 days. Wound closure will be monitored by an experienced surgeon. The exact area will be assessed using computerized planimetric determination.

Secondary

MeasureTime frame
Scar quality at three and 12 months after operation will be assessed using the POSAS, cutometer to measure scar elasticity, dermaspectometer to assess scar colour and Primos 3D to assess the smoothness of the scar.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)