Effect of postoperative negative pressure wound therapy (Prevena TM) in clean closed surgical incisions on the incidence of wound dehiscence in low and high risk patients: a rondomized controlled pilotstudy.

Effect of postoperative negative pressure wound therapy (Prevena TM) in clean closed surgical incisions on the incidence of wound dehiscence in low and high risk patients: a rondomized controlled pilotstudy. - DEhiscence PRevention Study II (DEPRES II)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42830

Enrollment

Registered

2017-06-14

Start date

2017-11-01

Completion date

Unknown

Last updated

2024-04-15

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/intervention group Prevena* Incision Management System is applicated in clean closed surgical incisions (7 days) In the controlgroup a simple wounddressing steristrips (care as us

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 * 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

Exclusion criteria: incompetence fistulas in the area of the incision

Design outcomes

Primary

Measure	Time frame
wound dehiscence woundinfection (Surgucal Site Infection)	—

Secondary

Measure	Time frame
pain (on wound dressing) skin tension pre operative and postoperative	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)