The aim of this study is to compare the effect of a postoperativenegative pressure dressing (Prevena (TM) IMS) with a standardwound dressing (care as usual) in clean closed surgical wounds on the prevention of wounddehiscence in low riks and high…
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
wound dehiscence
woundinfection (Surgucal Site Infection)
Secondary outcome
pain (on wound dressing)
skin tension pre operative and postoperative
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) in preventing this
complication. Case series are promesing.
In DEPRES I (2015-2016) the effect of Prevena TM was statistically significant
but mostly based on mild wound dehiscence , grade 1 and 2, (which can be
treated by care as usual like standard wound dehiscence) because mainly
patients without risk factors were included. In spite of former studies, good
quality scientific research on this intervention is lacking.
Study objective
The aim of this study is to compare the effect of a postoperativenegative
pressure dressing (Prevena (TM) IMS) with a standard
wound dressing (care as usual) in clean closed surgical wounds on the
prevention of wounddehiscence in low riks and high patients for wound
dehiscence undergoing an elective plastic surgical surgery
Study design
Open randomized controlled pilotstudy that will be performed in the Radboud
University Medical Center Nijmegen (plastic surgery) with n=80 patients. Low
risk patients will be allocated to either the interventiongroup (n=20) or the
control group (n=20) and high risk patients the interventiongroups (n=20) or
the controlgroup (n=20).
Intervention
In the experimental/intervention group Prevena* Incision Management System is
applicated in clean closed surgical incisions (7 days)
In the controlgroup a simple wounddressing steristrips (care as usual) is
applicated in clean closed surgical incisions (2 days)
Study burden and risks
allergy to the wounddressing
If necessary about 20 minutes extra time (exclusive travel time) for visiting
patient clinic
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
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
* no risk factor for wound dehiscence
* OR
* at least one risk factor for wound dehiscence:
- Diabetes Mellitus (DM)
- Body mass index >= 30
- active smoker (active and smoker in history)
- radiotherapy (Active and in history)
- COPD chronic obstructive pulmonary disease;AND patients undergoing one of the following elective sugical procedures:
o plastic surgery breastrecontruction through a abdominal transverse incision (DIEP flap or a typelike esthetical breastrecontruction)
o pressure ulcer surgery: for example rotation lap (skin and/or muscle fascia)
o VY-plasty technique
o TFL-flap (tensor fascia lata)
Exclusion criteria
incompetence
fistulas in the area of the incision
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 | NL60146.091.16 |