Orthopedic DisorderNCT06579599
Study on the Preventive Effect of Establishing an Integrated Working Group of Doctors and Nurses in Operating Room
A study testing an integrated working group nursing in people with Orthopedic Disorder and Incision Infection, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Orthopedic Disorder, Incision Infection
- What is being tested?
- an integrated working group nursing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) All selected cases met the relevant diagnostic criteria outlined in the orthopedic disease guidelines. Diagnosis was confirmed through imaging methods.
- The patients ranged in age from 18 to 70. (3) All individuals underwent surgery in the orthopedic department of our hospital.
- 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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Feng Huang, BA, 18758871337, 3220001@zju.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthopedic Disorder, Incision Infection
- Being tested
- an integrated working group nursing
- Keywords
- Orthopedic Disorder, Incision Infection, Operating room, Integration of medical staff
- Medical subject headings
- Musculoskeletal Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an integrated working group nursingOther
(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.
| Study group | Role | What they receive |
|---|---|---|
| Routine operating room nursing | No intervention | Routine nursing interventions were put into practice in the operating room for the control group. |
| an integrated working group nursing | Experimental | Received intervention through the establishment of an integrated working group comprising medical staff in the operating room. Receives: Other: an integrated working group nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incision infection rate
Incision infection rate = the number of postoperative incision infection / the total number of cases × 100%
Measured: One month after surgery
Secondary outcomes (3)
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%
Measured: 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
Measured: On the 1 day of discharge
Adverse nursing risk events
the total adverse nursing risk rate of the two groups
Measured: On the 1 day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start30 Dec 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Huang, BA, Principal investigator, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579599
- Sponsor's protocol ID
- KY-2024-143
- Status last verified
- Feb 2025
- First submitted
- 28 Aug 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06579599
- Acronym / sponsor ID
- KY-2024-143
- Conditions
- Orthopedic Disorder, Incision Infection
- Keywords
- Orthopedic Disorder, Incision Infection, Operating room, Integration of medical staff
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine operating room nursing | No intervention | –Routine nursing interventions were put into practice in the operating room for the control group. |
| an integrated working group nursing | Experimental | Other: an integrated working group nursingReceived intervention through the establishment of an integrated working group comprising medical staff in the operating room. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) All selected cases met the relevant diagnostic criteria outlined in the orthopedic disease guidelines. Diagnosis was confirmed through imaging methods.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | an integrated working group nursing |
Primary outcome
Incision infection rate
Time frame: One month after surgery
Incision infection rate = the number of postoperative incision infection / the total number of cases × 100%
3 secondary outcomes
Incision recovery
Time frame: On the 1 day of discharge
Nursing quality
Time frame: On the 1 day of discharge
Adverse nursing risk events
Time frame: On the 1 day of discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Orthopedic Disorder
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Not yet recruitingObservational study
Multimodal Mechanical, Tissue, Architectural, and Histological Evaluation of the Bone and Sutures of the Parietal Bone in an Infant With Craniosynostosis.
Craniostenosis
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Huang, BA principal investigator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an integrated working group nursing in people with Orthopedic Disorder and Incision Infection, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Huang, BA (18758871337, 3220001@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incision infection rate (time frame: One month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.