Effectiveness of Dermal Substitution and Negative Pressure Wound Therapy in Burns: a Randomized Controlled Pilot Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24206

Enrollment

Registered

2021-10-27

Start date

2021-12-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Burns

Interventions

Glyaderm, split thickness skin graft and negative pressure wound therapy

Eligibility

Inclusion criteria

Inclusion criteria: 1. Deep dermal to full thickness burn wounds requiring excision and skin grafting 2. Age =18 years old 3. Two anatomically comparable wounds of =10 cm2 or one wound surface area of =64 cm2 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Wounds not suitable for NPWT application 2. Solitary facial burns 3. Infected wounds 4. Patients suspected to be non-compliant, i.e. in case of severe cognitive dysfunction or psychiatric disorders 5. Pregnancy

Design outcomes

Primary

Measure	Time frame
Scar elasticity at 3, 6 and 12 months post-operatively	—

Secondary

Measure	Time frame
Graft take, epithelialisation, complications, scar pigmentation/vascularisation, POSAS observer/patient scale	—

Contacts

Public ContactElleke Munk

Radboudumc

elleke.munk@radboudumc.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)