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Perioperative Immunonutrition in Patients Undergoing Gynecologic or General Elective Surgery (PURPOSE)

NCT04057092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-05-25

No results posted yet for this study

Summary

The objective of the implementation pilot is to assess the practicality of introducing a perioperative immunonutrition protocol into a hospital environment as well as a true measure of impact on the rate of surgical site infection (SSI).

Conditions

  • Surgical Site Infection
  • Post-Op Complication

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement INergy-FLD

INergy-FLD® is an immune modulating formula containing various ingredients including L-Arginine, whey protein isolate, and omega-6 fatty acid, aimed to attenuate excessive inflammatory responses without being immunosuppressive and to replenish nutrients that are depleted in a state of surgical stress, thereby enhancing the recovery process and decreasing the risk of infection. The volume of the beverage is 250mL per serving and patients will be asked to consume 3 servings periodically per day for 5 days prior to surgery and 5 days following surgery.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-09-30
Completion
2020-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057092 on ClinicalTrials.gov