Dangling of the free flap. Gravity training of the free flap.
Conditions
Interventions
- No dangling protocol
- Patients randomized in group A at the UMC Utrecht will undergo blood tests
with the use of a Point Of Care Testing (POCT) device. Point of Care Testing is
a technique that o
Sponsors
Plastisch chirurgie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male or female - Age between 16 and 99 years old - Lower leg defect in need for a free flap reconstruction
Exclusion criteria
Exclusion criteria: - Age under 16 years - Co-morbidities that prevent the patient from being able to undergo a dangling protocol - Insufficient Dutch language skills to understand the study - Mentally incompetent, Patients that are unable to give informed consent - Reconstruction with 2 or more free flaps - In case the patient is getting a secondary free flap due to partial or total free flap necrosis of the primary one.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective parameter: to assess whether a no dangling protocol is non-inferior to a dangling protocol in terms of proportion of patients who experienced partial flaps loss which did not require another free lap procedure at six months after surgery. We defined complete flap necrosis, partial flap necrosis (if a revision surgery with a second free flap is necessary) and lung embolia as major complications. Screening for lung embolia will only be performed if there is a clinical suspection for a lung embolia. Partial flap loss is defined as minor if no secondary free flap is needed or major if a secondary free flap was needed. Wound dehiscence, wound infection, failure of skin graft take on the free flap, and hematoma for which a surgical exploration was needed were defined as the minor complications. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective parameters: - We hypothesize that there will be no difference in major complications at 6 months. - We would like to objectify the gaseous changes within the free flap during the dangling protocol in a selective group of patients. - We will measure the physical functions at 3 and 6 months, 1 year, 1,5 years and 2 years with the PROMIS, EQ-5D and VAS-score questionnaires. - We hypothesize that there is no difference in the number of patients experiencing one or more minor complications at three and six months post operative. - Investigate if there is a difference in the length of hospital stay between the two groups. - Investigate infection rates and osseous union rates with a follow up of two years based on the patients* medical files. | — |
Countries
Netherlands
Outcome results
None listed