|- candidate number||27340|
|- NTR Number||NTR6481|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-jun-2017|
|- Secondary IDs||HMC 2016-3615 METC 17-017|
|- Public Title||RCT incisional NPWT versus sterile surgical dressing for surgical wounds after arterial vascular surgery|
|- Scientific Title||Randomized controlled Clinical Trial incisional NPWT versus Sterile Surgical Dressing for surgical wounds after arterial vascular surgery|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Arterial vascular surgery|
|- Inclusion criteria|| Patients age above 18 year|
Mentally competent in order to give informed consent
Undergo one of the following surgical procedures:
- Bypass: aortic-iliacal, ilical-femoral, femoral-femoral, femoral-popliteal, femoral-crural, femoral-tibial
- Endarterectomy: iliacal, femoral
- Reconstruction aneurysm: femoral
- Embolectomy iliacal, femoral
Patients must be fit for surgery (regardless age or co-morbidities such as diabetes or obesity)
|- Exclusion criteria|| Patients age younger than 18 year|
Endovascular aortic procedures (EVAR with transverse groin incisions)
Aortic abdominal and thoracal procedures
Arterial surgical procedures of upper extremities
Allergy for the product such as acrylic adhesive coating or silver
Unable to provide informed consent
Unable to understand the Dutch language
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-mei-2017|
|- planned closingdate||15-mei-2020|
|- Target number of participants||270|
|- Interventions||Incisional Negative Pressure Wound Therapy for surgical closed incision (Prevena)|
|- 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.|
|- Timepoints||1,2,4 after surgery and date complete wound healing|
|- Trial web site||toetsing|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. E. Lenselink|
|- CONTACT for SCIENTIFIC QUERIES||Drs. E. Lenselink|
|- Sponsor/Initiator ||Haaglanden Medical Center, The Hague|
(Source(s) of Monetary or Material Support)
|Haaglanden Medical Center, The Hague|
|- Brief summary||SUMMARY|
Complications after vascular arterial surgery are common and can be very serious. They prolongs hospital stay and increases costs. In the Haaglanden Medical Centre both Incisional Negative Pressure Wound Therapy (INPWT) and Sterile Surgical Dressing (SSD) are used as post-operative dressings. There is growing evidence that INPWT might prevent surgical wound complications, which will promote patients wellbeing and decrease costs.
Primary Objective: to investigate if INPWT will prevent wound complications such as wound dehiscence, wound infection, seroma leakage 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.
A prospective randomized controlled clinical trial of two different postoperative wound treatments.
All patients that underwent vascular arterial surgery with one or more groin incisions. Except patients for Endovascular Abdominal Repair (EVAR).
Intervention (if applicable):
Incisional Negative Pressure Wound Therapy (Prevena ฎ) or sterile surgical dressing (Curaporฎ).
Main study parameters/endpoints:
Wound complications such as SSI, wound dehiscence, seroma leak and wound necrosis and complete wound healing.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Both therapies are standard and safe therapies and will not harm patients. Additional there will be no extra burden for the patients.
|- Main changes (audit trail)|
|- RECORD||1-jun-2017 - 6-jul-2017|