Application of a dermal substitute and topical negative pressure to improve the healing of burn wounds

Application of a dermal substitute and topical negative pressure to improve the healing of burn wounds - VAC-M

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30864

Enrollment

Registered

2007-10-26

Start date

2007-10-01

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 burns full thickness burns

Interventions

Group 1: the selected wound will be treated with dermal substitute Matriderm, split skin graft and VAC therapy Group 2: the selected wound will be treated with dermal substitute Matriderm, and split

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:-patients => 18 yrs with acute burns/trauma wounds that require skin grafting -Minimal study wound surface 10 cm2 -Maximal study wound surface 300 cm2 -maximal TBSA 15% full thickness wounds -Informed consent

Exclusion criteria

Exclusion criteria: Exclusion criteria: -Patients with wounds without adequate possibility to apply VAC -Immunocompromised patients -Infected wounds -Pregnant patients -Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders (e.g. borderline or depression).

Design outcomes

Primary

Measure	Time frame
Primary end point: skin elasticity parameters (representing scar quality) after 3 months	—

Secondary

Measure	Time frame
Secondary end points: take of graft after 5-7 days, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer) after 3 months	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)