Negative pressure wound therapy (NPWT) on closed incisions to prevent surgical site infection in HPB-surgery

Negative pressure wound therapy (NPWT) on closed incisions to prevent surgical site infection in HPB-surgery - NP-SSI-Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015136

Enrollment

222

Registered

2019-02-19

Start date

2019-05-01

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 T81.3

Interventions

Group 1: Wound treatment with Prevena incision management system for 7 days postoperatively Group 2: Treatment of the wound with plaster bandage for 7 days postoperatively

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patient >49 years of age undergoing hepato-pancreato-biliary surgery with midline, transverse or L-formed laparotomy - Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule - Written informed consent prior to any study procedures

Exclusion criteria

Exclusion criteria: - Patients not meeting the specified inclusion criteria - No primary closure of the wound - Planned 2nd look laparotomy

Design outcomes

Primary

Measure	Time frame
The primary aim of this study is to investigate if iNPWT provided by the PrevenaTM Incision Management System (KCI, San Antonio, Texas) reduces the incidence of superficial and deep incisional surgical site infection within 30 days after HPB-surgery compared to the standard of care.	—

Secondary

Measure	Time frame
Secondary aim s of the study are: - SSI (Surgical Site Infections) on day 7: This secondary objective is to find out if occult SSI during iNPWT treatment occur and if iNPWT influences the timepoint of SSI generation. - Evaluation of Surgical Site Complications (SSC) (hematoma, seroma, dehiscence, necrosis) on Day 7 and 30-37; beside the SSI also SSC represent important complications in HPB-surgery. If a significant reduction of SSC by iNPWT therapy could be achieved it would be as relevant as the reduction of SSI for the clinical practice. - Rate of fascial dehiscences within 30 days after operation - Assessment of the Quality of life using the EQ-5D-5L questionnaire on day 7 and on day 30 (evaluated between day 30 and 37); Quality of life is an important part of medical treatment. The EQ-5D-5L questionnaire is well established. - Usage of antibiotics because of SSI or other reason: The question if the iNPWT therapy leads to lower usage of antibiotics should be answered. - Rate of secondary interventions and re-operations o Due to SSI o Due to other reason	—

Measure

Time frame

Secondary aim s of the study are: - SSI (Surgical Site Infections) on day 7: This secondary objective is to find out if occult SSI during iNPWT treatment occur and if iNPWT influences the timepoint of SSI generation. - Evaluation of Surgical Site Complications (SSC) (hematoma, seroma, dehiscence, necrosis) on Day 7 and 30-37; beside the SSI also SSC represent important complications in HPB-surgery. If a significant reduction of SSC by iNPWT therapy could be achieved it would be as relevant as the reduction of SSI for the clinical practice. - Rate of fascial dehiscences within 30 days after operation - Assessment of the Quality of life using the EQ-5D-5L questionnaire on day 7 and on day 30 (evaluated between day 30 and 37); Quality of life is an important part of medical treatment. The EQ-5D-5L questionnaire is well established. - Usage of antibiotics because of SSI or other reason: The question if the iNPWT therapy leads to lower usage of antibiotics should be answered. - Rate of secondary interventions and re-operations o Due to SSI o Due to other reason

—

Countries

Germany

Contacts

Public ContactFrank Brennfleck

Universitätsklinikum Regensburg

allgemein.chirurgie@ukr.de09419446801

Outcome results

None listed

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