The Effect of Bundle Application on Surgical Site Infection

NCT06724354 | Completed DMC

• 1 other identifier: CukurovaU-HEKK-BB-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical site infections (SSI) are the most common complications after surgical operations and are in the top three in Healthcare Associated Infections (HIE). Due to surgical site infections, morbidity, mortality and hospital stay in postoperative patients increase, as well as the cost of treatment. The World Health Organization (WHO) has published a list of infection control measures, including preoperative, intraoperative and postoperative precautions, in the guideline for the prevention of SSI. The aim of infection control is to minimize preventable risks. It is recommended to use evidence-based practices for this purpose. Care packages consisting of combining and using high-evidence applications are applications that can benefit the patient. When these applications are done individually, they benefit the patient, but applying them all in the same package gives better results. In the care given using the care package, the health team creates a common language. The fact that these applications are evidence-based provides the opportunity to control patient care, while reducing the cost and complications. Despite advances in healthcare, SSI is still one of the major causes of morbidity and mortality. Although perioperative infection prevention packages are frequently applied in fields such as general surgery and orthopedic surgery, there are few studies stated that they are applied in neurosurgery operations where the defense mechanism against microorganisms is very low. However, SSI seen after cranial surgery may also cause an increase in morbidity and mortality. It is aimed to reduce CAE with the increasing use of package applications in developed and developing countries in recent years, and it is seen that positive results have been obtained from the studies on package application. However, when the domestic literature was searched, no study on the subject was found. It is thought that the planned study will contribute to the literature in terms of supporting the perioperative recovery of the measures taken to reduce the infection rate.

Conditions

Craniotomy Surgery; Preventive Health Care

Keywords

Care package,; surgical site infection; infection rate; healthcare associated infection

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection rate

  The Surgical Site Infection Prevention Care Package applied after cranial surgery has an effect on the rate of SSI development.

  30 days

Study Arms (2)

intervention group

ACTIVE COMPARATOR

The patients in the experimental group were applied a care package protocol. Before the surgery; ensuring that the patient takes a shower, the necessity of shaving, the application of appropriate surgical prophylaxis, and the provision of preoperative glycemic control were applied to the experimental group. During the surgery; ensuring appropriate surgical hand hygiene, complying with aseptic technique, preparing the skin with appropriate antiseptic solution, keeping the patient's body temperature above 36°C during the surgery, repeating antibiotic prophylaxis in prolonged surgeries, and ensuring optimum oxygenation were applied. After the surgery; ensuring aseptic technique during dressing, ensuring hand hygiene before and after each intervention to the wound, not opening the wound for the first 48 hours, not continuing surgical antibiotic prophylaxis for more than 24 hours after the surgery, and the provision of postoperative glycemic control were applied.

Other: The Surgical Site Infections Precaution Package Form includes the parameters that should be applied to patients before, during and after surgery.

control group

NO INTERVENTION

The infection prevention package parameters were not applied and the routine practice of the clinic was continued.

Interventions

The Surgical Site Infections Precaution Package Form includes the parameters that should be applied to patients before, during and after surgery. OTHER

Surgical site infections are a preventable cause of morbidity following surgical procedures. Strategies to reduce SSI rates should address preoperative, perioperative and postoperative factors, and multiple interventions can be combined into 'bundles'. Adoption of these measures may reduce SSIs, but this is dependent on a high level of package compliance. The aim of this study was to evaluate the change in SSI rates after the implementation of the SSI prevention package after neurosurgical operations. It is thought that if the results of our study are positive, the package form created will be pioneered for use in other patient groups. In addition, reducing SSI rates will shorten the postoperative recovery time of patients and reduce hospital costs.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those over the age of 18, Those who have had craniotomy surgery, Those who do not have a diagnosed psychiatric disease, Those who have had elective surgery, Those who have had surgery for the first time

You may not qualify if:

• Those who underwent emergency surgery, Those who were pregnant, Those who had a foreign object inserted during surgery, Those who had an infection during hospitalization, Those who underwent surgery for the second time with the same surgery code, Those who refused to participate in the study by themselves or their relatives.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Health Application and Research Center Balcali Hospital

Adana, Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical Wound Infection; Cross Infection

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Belgin Birgül

  Cukurova University Health Application and Research Center Balcali Hospital

  PRINCIPAL INVESTIGATOR

• Erden Sevilay

  Cukurova University Faculty of Health Sciences Department of Surgical Diseases

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nursing

Model Details: The study is a randomized controlled intervention study to investigate the effect of the care bundle application on surgical site infection rate in cranial brain surgery.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2024
• Primary Completion: March 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)