Study on the Preventive Effect of Establishing an Integrated Working Group of Doctors and Nurses in Operating Room

Study on the Preventive Effect of Establishing an Integrated Working Group of Doctors and Nurses in Operating Room on Incision Infection in Orthopedic Surgery and Its Clinical Enlightenment

To explore the preventive effect and clinical enlightenment of establishing an integrated working group of doctors and nurses in operating room on incision infection in orthopedic surgery.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Disorder; Incision Infection
• Intervention / Treatment: Other: an integrated working group nursing

Detailed Description

Surgery is the most used treatment in orthopedics. During orthopedic surgery, the integrity of the skin barrier is compromised, resulting in direct exposure of sterile tissue to the external environment and the potential impact of surgical instruments on local tissue. Additionally, orthopedic surgery procedures often entail prolonged duration, extensive surgical areas, and significant blood loss, all of which contribute to an elevated risk of surgical site infections. However, there are some limitations in the practical application of the conventional nursing model in the operating room. Against this backdrop, numerous new nursing models have emerged to meet contemporary demands. Among them, the integration of medical and nursing staff (MANS) in the operating room has garnered significant attention. Presently, this integrated model is predominantly employed in critical care settings and for postoperative infection prevention. However, the establishment and effectiveness of an integrated working group comprising both MANS in the operating room remains in its nascent stage of exploration, warranting further investigation into its clinical impact and implications.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Huang, BA; Phone Number: 18758871337; Email: 3220001@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Yiwu, Zhejiang, China, 322000
      • Recruiting
      • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Feng Huang, BA; Phone Number: 18758871337; Email: 3220001@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) All selected cases met the relevant diagnostic criteria outlined in the orthopedic disease guidelines. Diagnosis was confirmed through imaging methods.

  (2) The patients ranged in age from 18 to 70. (3) All individuals underwent surgery in the orthopedic department of our hospital.

  (4) The vital signs of the patients were essentially stable. (5) Patients possessed normal cognitive function before the operation and demonstrated the ability to listen, speak, read, and write.

Exclusion Criteria:

• (1) Orthopedic patients with multiple injuries in other locations (such as craniocerebral trauma, chest trauma, etc.); (2) Patients with severe internal diseases, such as severe anemia, severe diabetes, liver insufficiency; (3) Patients with chronic infectious diseases; (4) Patients with malignant tumor; (5) Patients with pathological fracture, such as bone tumor; (6) Patients with mental diseases and cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine operating room nursing; Routine nursing interventions were put into practice in the operating room for the control group.
Experimental: an integrated working group nursing; Received intervention through the establishment of an integrated working group comprising medical staff in the operating room.	Other: an integrated working group nursing; (1) Establishment of an integrated team in the operating room; (2) Development of a nursing plan; (3) Nursing safety training and reflection in the operating room; (4) Designate a person to manage instruments and equipment in the operating room and establish protocols (5) Nurses should also participate in the development of the patient's individualized surgical plan communicate with the surgeon about the preparation of items needed for surgery to ensure seamless coordination. Assist anesthesiologists and surgeons and oversee the implementation of aseptic procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incision infection rate	Incision infection rate = the number of postoperative incision infection / the total number of cases × 100%	One month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incision recovery	On the day of discharge, the effect of incision healing was evaluated by the doctor and recorded by the nurse, including excellent: the surgical incision basically healed without adverse reactions; good: poor healing, mild redness, swelling and induration around the incision, but no suppuration; poor: the incision has been infected and suppurate. Excellent and good rate = (excellent + good) cases / total cases × 100%	On the 1 day of discharge
Nursing quality	The nursing quality management questionnaire of operating room made by our hospital was used, and the quality control department staff or head nurse made an unannounced visit to evaluate the nursing quality	On the 1 day of discharge
Adverse nursing risk events	the total adverse nursing risk rate of the two groups	On the 1 day of discharge

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: Feng Huang, BA, The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Orthopedic Disorder; Operating room; Incision Infection; Integration of medical staff
• Additional Relevant MeSH Terms: Wounds and Injuries; Postoperative Complications; Pathologic Processes; Wound Infection; Surgical Wound; Infections; Musculoskeletal Diseases; Surgical Wound Infection
• Other Study ID Numbers: KY-2024-143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No