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

Dehiscence Prevention Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28116

Enrollment

Registered

2016-04-25

Start date

2015-02-12

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Humans, post operative care, elective abdominale surgery, elective othopedic surgery, elective vascular surgery, elective plastic surgery (Deep Internal Epigastric Perforator flap (DIEP-flap) and Profunda Artery Perforator flap (PAP-flap), wound dehiscence

Interventions

In 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 surgic

Eligibility

Inclusion criteria

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 plastic surgery through a transverse abdominal (DIEP flap) or sublgluteal (PAP flap) 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 the suture line

Exclusion criteria

Exclusion criteria: - incompetence - open fracture - fistula(s) in the area of the incision - simultaneous participation in another scientific study

Design outcomes

Primary

Measure	Time frame
wound dehiscence measured by visible wound dehiscence (wound dehiscence was measured in centimeters)	—

Secondary

Measure	Time frame
1 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	—

Contacts

Public ContactEmmy Muller-Sloof

Radboud University Medical Center

Emmy.Muller-Sloof@Radboudumc.nlM 00 31 (0) 611090325

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)