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

Phase 2

• Conditions: T81.4; L08.8; Y84.9; Infection following a procedure, not elsewhere classified; Other specified local infections of skin and subcutaneous tissue; Medical procedure, unspecified

• Registration Number: DRKS00015531
• Lead Sponsor: Asklepios Klinik Langen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-07-04
• Study Start: 2020-11-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

All adult patients, elective laparotomies

Exclusion Criteria

Minors, emergency laparotomies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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