Reducing surgical site infection by prophylactic negative pressure wound therapy in a cohort of general surgery patients - Implementing an improvement study by using a two stages single arm trial protocol

Reducing surgical site infection by prophylactic negative pressure wound therapy in a cohort of general surgery patients - Implementing an improvement study by using a two stages single arm trial protocol - PICO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015531

Enrollment

Registered

2020-11-23

Start date

2019-03-20

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

T81.4 L08.8 Y84.9

Interventions

Group 1: Post-operatively in elective laparotomies after closure of the abdomen a negative pressure wound dressing is applied to the laparotomy wound for 7 days through the PICO® system.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All adult patients, elective laparotomies

Exclusion criteria

Exclusion criteria: Minors, emergency laparotomies

Design outcomes

Primary

Measure	Time frame
Surgical site infection (SSI) defined according to CDC grade 1 (superficial), grade 2 (deep), and grade 3 (organ) on the 7th and 30th postoperative days. Follow-up on the 30th post-op day via telephone interview according the "post-stationary questionnaire for surgical wound healing"	—

Secondary

Measure	Time frame
Hematomas, seromas and postoperative complications defined by Clavien-Dindo-Complication Score (grade 1-5) and NNIS Risk Index Score (0-3 points) of the CDC USA	—

Countries

Germany

Contacts

Public ContactVladimir Piroski

Asklepios Klinik Langen - Klinik für Allgemein-, Viszeral- und Thoraxchirurgie / Akademisches Lehrkrankenhaus der Goethe-Universität / Regionales CHIR-Net Zentrum

v.piroski@asklepios.com06103 912 1309

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026