open colorectal surgery
Conditions
Interventions
Group 1: Postoperative wound coverage with negative pressure incisional therapy device (PrevenaTM Incision Management System) for 5-7 days postoperative.
Group 2: Postoperative wound coverage with st
Sponsors
Klinikum rechts der Isar,Technische Universität München
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.) Planned elective open colorectal surgery via median or transverse laparotomy 2.) Age 18 years or older 3.) Ability to understand the nature and extend of the trial and to sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1.) Pregnancy or breast-feeding 2.) Median or transverse laparotomy within the last 60 days prior to inclusion into the study. 3.) Planned relaparotomy within 30 days 4.) Laparoscopic or laparoscopic assissted surgery 5.) Patients on preoperative antibiotic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of surgical site infections according to the definition of the Centers for Disease Control and Prevention within 30 days postoperative. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.) Length of hospital stay 2.) Rate of reoperations 3.) Rate of antibiotic theray 4.) Duration of postoperative negative pressure incision therapy (intervention arm only) 5.) Wound pain assessed with visual analogue scale 6.) Rate of wound complications other than wound infections 7.) Rate of serious adverse events | — |
Countries
Germany
Contacts
Public ContactRebekka Schirren
Chirurgische Klinik und Poliklinik,Klinikum rechts der Isar,Technische Universität München
Outcome results
None listed