Comparison of negative pressure incisional therapy with conventional plaster in regard to post-surgical site infections after urgent laparotomies in acute cases of gastro-intestinal disorders.
Conditions
Interventions
Group 1: After skin closure of laparotomy patients in the experimental intervention receive negative pressure incisional therapy (PREVENA™, KCI Medizinprodukte GmbH, Wiesbaden).
The negative pressure
Sponsors
Philipps-Universität Marburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: •Patients with indication for urgent laparotomy due to an acute gastro-intestinal disorder •age = 18 years •life expectancy > 12 months •Written informed consent of the patient or the patient’s legal representative
Exclusion criteria
Exclusion criteria: •Inpatient treatment longer than 4 days before urgent surgery •Previous transverse or median laparotomy, if it is necessary to reopen it again •Allergy or hypersensitivity against silver or acrylic adhesives •pregnancy •participation in an interventional study with interfering endpoints •neurophysiological deficits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of post-surgical site infections of category A1 (superficial) and A2 (deep) within 30 (+7) days after surgery in patients without revision. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prolongation of hospitalisation due to post-surgical site infection, cosmetic result, safety endpoints: AEs, SAEs. | — |
Countries
Germany
Contacts
Public ContactDetlef Bartsch
Klinik für Viszeral-, Thorax- und Gefäßchirurgie Philipps-Universität Marburg
Outcome results
None listed