Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

June 12, 2023

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed

13 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed

Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 22, 2023

Last Update Submit

June 30, 2023

Conditions

Bariatric Surgery Candidate

Keywords

Surgical Site InfectionBariatric SurgeryCare bundleprevention package

Outcome Measures

Primary Outcomes (1)

Surgery Site Infection
The Centers for Disease Control and Prevention (CDC) defined SSI as an infection secondary to surgery in the superficial, deep or organ cavity within 30 days of surgery. On the 7th day after surgery, the wound will be observed for infection while the stitches are removed. In the presence of symptoms such as purulent discharge, pain, increased redness, swelling and tenderness in the surgical area within 30 days, they will be referred to a health institution for the detection of SSI
The infection will be evaluated in the hospital on the 7th day after surgery. An evaluation will be made by phone call on the 30th day after the operation.

Secondary Outcomes (1)

Perianesthesia Comfort Scale
Postoperative 0-1. day

Study Arms (6)

Surgical Site Infection (SSI) prevention package; Identification of risk factors

EXPERIMENTAL

Risk factors of the individual created in line with the literature; Advanced age, history of skin or soft tissue infection, DM, alcohol addiction, smoking, preoperative albumin \<3.5 mg/dl, total bilirubin\>1.0 mg/dl, immunosuppression, long postoperative stay, long preoperative stay, high BMI,ASA score \> II,preoperative low Hgb level. Risk factors associated with the surgical procedure; Presence of drain, prolongation of surgery time, preoperative skin preparation, blood transfusion, non-sterile equipment, insufficient ventilation, heavy operating room traffic, insufficient hemostasis. Participants will be evaluated in terms of these risks.