Primary Objective: to investigate if INPW will reduce wound complications such as wound dehiscence, wound infection (SSI), seroma leak and wound necrosis after arterial vascular surgery.Secondary Objective(s): to investigate if INPWT will prevent…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of wound complications such as wound infection, wound dehiscence,
seroma leak and wound necrosis.
Secondary outcome
Complete wound healing percentages and time till complete wound healing.
Hospital stay in days, additional surgery, re-admissions, extra visits to the
outpatient clinic in numbers.
Background summary
In general there is evidence that INPWT will reduce wound complications however
data in vascular studies present inconclusive results regarding the reduction
of wound complications after vascular surgery and more specific the reduction
of wound dehiscence. However due to the high number of wound complications in
our recent study it is important to look for a management which will reduce
those complications. Therefore the current study will investigate if INPWT will
reduce wound complications compared with sterile surgical dressing( SSD).
Study objective
Primary Objective: to investigate if INPW will reduce wound complications such
as wound dehiscence, wound infection (SSI), seroma leak and wound necrosis
after arterial vascular surgery.
Secondary Objective(s): to investigate if INPWT will prevent additional
surgery, prolonged hospital stay, re-admissions and extra visits to the
outpatient clinic, and thereby and reduce costs.
Null hypothesis:
There is no differences in amount and seriousness of wound complications
between the INPWT and SSD wound application technique after vascular surgery at
the groin.
Study design
The study design is a prospective observational Randomized Clinical Trial. Due
to the nature of the treatments blinding is not possible.
Study burden and risks
Since this study compared to existing therapies, there is no risk of harm to
the participants.
Lijnbaan 32
Den Haag 2512VA
NL
Lijnbaan 32
Den Haag 2512VA
NL
Listed location countries
Age
Inclusion criteria
• Bypass: aortic-iliacal, ilical-femoral, femoral-femoral, femoral-popliteal,
femoral-crural, femoral-tibial
• Endarterectomy: iliacal, femoral
• Reconstruction amorism: femoral
• Embolectomy iliacal, femoral
Exclusion criteria
Endovascular aortic procedures iliacal (groin incision)
Aortic abdominal and thoracal procedures
Arterial surgical procedures of upper extremities
Silver allergy
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60311.098.17 |