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RCT incisional NPWT versus sterile surgical dressing for surgical wounds after arterial vascular surgery

Randomized controlled Clinical Trial incisional NPWT versus Sterile Surgical Dressing for surgical wounds after arterial vascular surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26008
Enrollment
270
Registered
2017-06-01
Start date
2017-05-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient who underwent arterial vascular surgery with surgical incision at the groin. gesloten liesincisie na arteriële vaatchirurgie vanwege PAOD

Interventions

Incisional Negative Pressure Wound Therapy for surgical closed incision (Prevena)

Sponsors

Medical Centre Haaglanden
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Incidence of wound complications such as wound infection, wound dehiscence, seroma leak and wound necrosis.

Secondary

MeasureTime frame
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.

Contacts

Public ContactE. Lenselink

Wondpoli HMC Westeinde

prevenastudie@haaglandenmc.nl088 979 1608

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)