CompletedNot Applicable

Efficacy of NPWT in Reducing the Incidence of Wound Infection After Pancreatic Surgery

Italy100 participantsStarted 2018-07-25

Plain-language summary

A disposable negative wound pressure device will be compared to standard sterile wound dressing in reducing the rate of wound infection after clean-contaminated surgical procedures on biliary tract and pancreas in patients at high risk for wound infection.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 * Informed consent * HPB clean-contaminated procedures (PD, TP and GEA/HJ) * Median laparotomy * Compliance with a follow-up protocol * High risk for SSI (at least one of the following): * Body Mass Index \> 30kg/m2 * Diabetes mellitus type I or II * Use of steroids * Neoadjuvant therapy * ASA ≥ 3 * Charlson Comorbidity Index 1 * Time of surgery \> 360' * Estimated blood loss \> 1L Exclusion Criteria: * Previous open surgery of the abdomen * Unable to give informed consent

What they're measuring

Surgical Site Infection (non-organ space)

Timeframe: 30 days from index surgery

Trial details

NCT IDNCT03700086

SponsorAzienda Ospedaliera Universitaria Integrata Verona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-10

View on ClinicalTrials.gov More Surgical Site Infection trials