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The Effect of the Care Bundle to be Applied to Obesity Surgery Patients on Surgical Site Infection and Patient Comfort

NCT05930639 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-07-05

No results posted yet for this study

Summary

One of the most effective treatment methods of obesity is surgery. Bariatric surgery is classified as a clean-contaminated wound. The expected benefit from surgery is weight loss. However, surgical site infection is among the complications. Although many methods are applied to reduce these rates, it is not very possible to reduce them to zero. It is predicted that the incidence of infection will decrease with surgical care packages created from the combination of evidence-based interventions applied.

This study was a randomized controlled trial designed to determine the effect of the Surgical Site Infection (SSI) prevention package on SSI and patient comfort in patients undergoing bariatric surgery.

The questions to be answered by the research are;

* What is the effect of the care package applied to patients undergoing bariatric surgery on surgical site infection?
* What is the effect of the care package applied to patients undergoing bariatric surgery on comfort? .Patients aged 18 and over who have had bariatric surgery (sleeve gastrectomy) will be taken from a private hospital in Kayseri. All surgeries will be performed by the same surgeon. The care package (identification of risk factors, antibiotic prophylaxis, normothermia, normoglycemia and patient education) prepared for the experimental group will be applied. On the 30th day, the patient is called by phone and the surgical site infection findings are questioned.

Conditions

  • Bariatric Surgery Candidate

Interventions

OTHER

Surgical Site Infection (SSI) prevention package

Care package components to be applied to the intervention group; identification of risk factors, antibiotic prophylaxis, normothermia, normoglycemia and patient education. Risk factors will be evaluated when the patient is admitted to the clinic. Antibiotics (imipenem + cilastatin sodium) routinely administered by the institution before surgery will be administered in both groups. Passive heating methods will be used to maintain body temperature for the first 24 hours after surgery. In the perioperative period, the blood glucose level will be kept below 200mg/dl for 48 hours. Before the operation and before discharge, the patient is educated about infection prevention measures.

Sponsors & Collaborators

  • Malatya Turgut Ozal University

    lead OTHER

Principal Investigators

  • Meryem YILMAZ · SİVAS CUMHURİYET UNIVERSITY

  • Hatice ÇAKIR · MALATYA TURGUT ÖZAL UNIVERSITY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2023-09-30
Completion
2023-10-31

Countries

  • Turkey (Türkiye)

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 NCT05930639 on ClinicalTrials.gov