Effectiveness of Dermal Substitution and Negative Pressure Wound Therapy in Burns: a Randomized Controlled Pilot Study
- Conditions
- Burns
- Registration Number
- NL-OMON24206
- Lead Sponsor
- ot applicable.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scar elasticity at 3, 6 and 12 months post-operatively
- Secondary Outcome Measures
Name Time Method Graft take, epithelialisation, complications, scar pigmentation/vascularisation, POSAS observer/patient scale