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The effect of postoperative negative pressure wound therapy on the incidence of wound dehiscence in high risk patients


- candidate number24299
- NTR NumberNTR5808
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-apr-2016
- Secondary IDs51649 (ABR-nummer) NL51649.091.14 (2014-1443)
- Public TitleThe effect of postoperative negative pressure wound therapy on the incidence of wound dehiscence in high risk patients
- Scientific TitleDehiscence Prevention Study
- ACRONYMDEPRES
- hypothesisWound dehiscence is the rupturing or splitting apart of the margins of a clean closed incision, which generally appears in the first week after surgery.
The aim of this study is to answer the question whether postoperative treatment with a wound dressing with negative pressure (Prevena™ Incision Management System) decreases the incidence of wound dehiscence compared to a wound dressing without negative pressure (standard wound dressing/ care as usual) in patients who are at risk for wound dehiscence and who undergo an elective abdominal, orthopedic, vascular or plastic surgical procedure.
- Healt Condition(s) or Problem(s) studiedPost operative, Wound infection, Surgery
- Inclusion criteria* male and female persons
* age 18 years or older
* signed informed consent form
* able to understand the Dutch language
* able to understand procedures and instructions
* patients undergoing 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 abdominal incision
* patients with at least one risk factor for wound dehiscence like:
o chronic obstructive pulmonary disease
o diabetes mellitus
o peripheral artery disease
o body mass index >30
o smoking
o radiotherapy in history
o earlier surgery in the same area
o traction on clean closed surgical incision
- Exclusion criteria- incompetence
- open fracture
- fistula(s) in the area of the incision
- simultaneous participation in another scientific study
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-feb-2015
- planned closingdate
- Target number of participants450
- InterventionsIn the experimental group Prevena™ Incision Management System is applicated in clean closed surgical incisions.

In the controlgroup a simple cotton wound dressing is applicated in clean closed surgical incisions. (care as usual, according to the CDC- Guidlines for Surgical Site Infection, 2014)
- Primary outcomewound dehiscence
measured by visible wound dehiscence (wound dehiscence was measured in centimeters)
- Secondary outcome1 surgical site infection measured when clinical signs of surgical site infection are present and by measuring the temperature of the body

2 pain is measured by asking for the patiënt's pain experience by using the Numeric Rating Scale of Pain (NRS)

3 allergy on the wound dressing measured by signs of allergy like: erythema, itch, edema, hematoma
- TimepointsT-1 = inclusion/exclusioncriteria, informed consent form, patiënts characteristics
T0 = surgery data
T1- T7 (1 week)= registration of body temperature, blood pressure, heart frequency, blood oxygen level, pain (NRS-score), allergy on the wound dressing, wound dehiscence
T8 = (4 weeks after surgery)= registration of pain (NRS-score), allergy on the wound dressing, wound dehiscence
- Trial web sitewww.toetsingonline.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc Emmy Muller-Sloof
- CONTACT for SCIENTIFIC QUERIESMSc Emmy Muller-Sloof
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Ministry of OC&W
- Publicationsnon
- Brief summaryWound dehiscence is a serious postoperative complication with high morbidity and high mortality (up to 50%) and contributes to delays in the recovery process and to prolonged hospital stays.
Several case series show the positive effect of Prevena™ Incision Management System in the prevention of wound dehiscence, but good quality scientific research on this intervention is lacking. This randomized controlled study on this intervention (Prevena™ Incision Management System) is started in February 2015 in the Netherlands at the Radboud University Medical Center of Nijmegen. This study is still going.

The aim of this study is to answer the question whether postoperative treatment with a wound dressing with negative pressure (Prevena™ Incision Management System) decreases the incidence of wound dehiscence compared to a wound dressing without negative pressure (standard wound dressing/care as usual) in patients who are at risk for wound dehiscence and who undergo an elective abdominal, orthopedic, vascular or plastic surgical procedure.
- Main changes (audit trail)
- RECORD25-apr-2016 - 7-feb-2017


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