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Effect of a negative pressure dressing (Prevena TM) on the prevention of wound dehiscence in clean closed surgical incisions: a rondomized controlled trial.

Effect of a negative pressure dressing (Prevena TM) on the prevention of wound dehiscence in clean closed surgical incisions: a rondomized controlled trial. - Dehiscence Prevention Study (DEPRES)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42308
Enrollment
450
Registered
2015-02-12
Start date
2015-02-11
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Wound dehiscence

Interventions

In the experimental group Prevena* Incision Management System is applicated in clean closed surgical incisions. In the controlgroup a simple cotton wounddressing (care as usual) is applicated in cle

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * age 18 years or older * signed informed consent form * able to understand the Dutch language * able to understand procedures and instructions * at least one risk factor for wound dehiscence - chronic obstructive pulmonary disease - diabetes mellitus - peripheral artery disease - body mass index >= 30 - Active smoker - Radiotherapy in history - Earlier surgery in the same area AND the patient undergoes one of the following elective sugical procedures: o abdominal surgery through median laparotomy, o vascular surgery through median laparotomy, upper leg and/or lower leg o orthopedic surgery: hemipelvectomy, total knee replacement o plastic surgery through a transverse suprapubic incision.

Exclusion criteria

Exclusion criteria: incompetence open fracture fistulas in the area of the incision simultaneous participation in another study

Design outcomes

Primary

MeasureTime frame
wounddehiscence

Secondary

MeasureTime frame
surgical site infection pain allergy for the wounddressing

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)