The Dangle Study
Completed
- Conditions
- Dangling of the free flap. Gravity training of the free flap.1001732210041297
- Registration Number
- NL-OMON50700
- Lead Sponsor
- Plastisch chirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
- Male or female
- Age between 16 and 99 years old
- Lower leg defect in need for a free flap reconstruction
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective parameter: to assess whether a no dangling protocol is<br /><br>non-inferior to a dangling protocol in terms of proportion of patients who<br /><br>experienced partial flaps loss which did not require another free lap procedure<br /><br>at six months after surgery. We defined complete flap necrosis, partial flap<br /><br>necrosis (if a revision surgery with a second free flap is necessary) and lung<br /><br>embolia as major complications. Screening for lung embolia will only be<br /><br>performed if there is a clinical suspection for a lung embolia. Partial flap<br /><br>loss is defined as minor if no secondary free flap is needed or major if a<br /><br>secondary free flap was needed. Wound dehiscence, wound infection, failure of<br /><br>skin graft take on the free flap, and hematoma for which a surgical exploration<br /><br>was needed were defined as the minor complications. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objective parameters:<br /><br>- We hypothesize that there will be no difference in major complications at 6<br /><br>months.<br /><br>- We would like to objectify the gaseous changes within the free flap during<br /><br>the dangling protocol in a selective group of patients.<br /><br>- We will measure the physical functions at 3 and 6 months, 1 year, 1,5 years<br /><br>and 2 years with the PROMIS, EQ-5D and VAS-score questionnaires.<br /><br>- We hypothesize that there is no difference in the number of patients<br /><br>experiencing one or more minor complications at three and six months post<br /><br>operative.<br /><br>- Investigate if there is a difference in the length of hospital stay between<br /><br>the two groups.<br /><br>- Investigate infection rates and osseous union rates with a follow up of two<br /><br>years based on the patients* medical files. </p><br>