The aim of this study is to compare the effectiveness of a negative pressure dressing (Prevena (TM) IMS) with a standard wound dressing (care as usual) in clean closed surgical wounds on the prevention of wounddehiscence in patients, undergoing an…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Skin and subcutaneous tissue disorders NEC
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
wounddehiscence
Secondary outcome
surgical site infection
pain
allergy for the wounddressing
Background summary
Wound dehiscence is the rupturing or splitting apart of the edges of a wound
closure. Wound dehiscence is a severe postoperative complication with a high
morbidity and mortality.
Prevena (TM) IMS is a new aid (negative pressure dressing) to prevent this
complication. Case series are promesing. However, good quality scientific
research on this intervention is lacking.
Study objective
The aim of this study is to compare the effectiveness of a negative pressure
dressing (Prevena (TM) IMS) with a standard wound dressing (care as usual) in
clean closed surgical wounds on the prevention of wounddehiscence in patients,
undergoing an elective general, vascular, orthopedic or plastic surgical
procedure and who are at high for wounddehiscence.
Study design
Open randomised controlled trial that will be performed in the Radboud
University Medical Center Nijmegen, with a sample size of 450 (α = 0,05; 1- ß =
0,8).
Intervention
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 clean closed surgical incisions.
Study burden and risks
allergy for the wounddressing
If necessary about 20 minutes extra time (excl. travel time) when the patient
has to visit the out patient clinic.
Geert Grooteplein-Zuid
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid
Nijmegen 6525 GA
NL
Listed location countries
Age
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
incompetence
open fracture
fistulas in the area of the incision
simultaneous participation in another study
Design
Recruitment
Medical products/devices used
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 | NL51649.091.14 |