An interventional study of immunonutrition and oral chlorhexidine decontamination in Postoperative Complications, sponsored by Huang YuGuang. Recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Huang YuGuang · Not applicable, Interventional, and Prevention
Elderly patients are vulnerable to postoperative complications. Preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. This study aims to investigate the feasibility and efficacy of perioperative oral decontamination and immunonutrition supplement on reducing postoperative complications in elderly surgical patients.
This study is a prospective, single center, two-by-two factorial randomized controlled trial to evaluate the feasibility and efficacy of perioperative oral chlorhexidine decontamination and immunonutrition supplementation on postoperative complications in elderly surgical patients. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited and randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care with/without immunonutrition supplementation).
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's planned enrollment of 590 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Huang YuGuang is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
Dietary Supplement: immunonutrition · Behavioral: oral chlorhexidine decontamination
Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and routine oral care.
Dietary Supplement: immunonutrition
Patients will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
Behavioral: oral chlorhexidine decontamination
Patients will be advised to follow a standard nutrition advice and routine oral care.
Patients in the intervention group will receive additional immunonutrition supplementation, which is oral intake of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery.
Patients in the intervention group will receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
postoperative pulmonary complications
evaluated by trained investigator
Time frame: within 7 days after surgery
postoperative pneumonia
defined according to the US Centers for Disease Control Definition
Time frame: within 7 days after surgery
postoperative recovery
evaluated by QoR-15 and WHODAS2.0
Time frame: within 30 days after surgery
Comprehensive complication index (CCI)
postoperative complication evaluated using Comprehensive complication index
Time frame: within 30 days after surgery
Length of hospital stay
Postoperative length of hospital stay assessed by days
Time frame: From date of surgery until discharge day, assessed up to 4 weeks
Plan to share: No
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