A multicenter randomized controlled trial comparing long term scar quality after hydrosurgical versus conventional tangential excision of deep dermal burns

A multicenter randomized controlled trial comparing long term scar quality after hydrosurgical versus conventional tangential excision of deep dermal burns - Scar quality after tangential excision of burns

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43015

Enrollment

137

Registered

2017-01-10

Start date

2017-01-20

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Burn injury

Interventions

Prior to surgery the study wound will be divided into two parts of equal size, which are randomly allocated to either conventional or hydrosurgical tangential excision. Two punch biopsies of both in

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Deep dermal burns of at least 50cm2 who require primary excision and grafting.

Exclusion criteria

Exclusion criteria: - No operation indication - TBSA 30% - Full thickness burns - Chemical or electrical burns - Infected wounds - No informed consent - Patients that are unlikely to comply with requirement of the study protocol and follow-up

Design outcomes

Primary

Measure	Time frame
The main study parameter is scar quality assessed as the POSAS (Patient and Observer Scar Assessment Scale) Observer Score at 12 months post-burn scored by 2 blinded observers independently.	—

Secondary

Measure	Time frame
In addition we compare dermal preservation after the two different kinds of surgery and calculate the Minimal Important Change of the POSAS. This is the minimal difference in scar quality that patients experience as important.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)