Researching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery

January 15, 2024 updated by: Xijing Hospital

A Controlled Clinical Study on the Safety and Effectiveness of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery

Through a single-center, exploratory clinical study, the safety and effectiveness of using barb wire in the incision and suture of posterior cervical surgery in obese patients were evaluated, providing a basis for its wide clinical application in posterior cervical surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shannxi Province
      • Xi'an, Shannxi Province, China, 710034
        • Recruiting
        • Jia Yanyan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis.
  • Preoperative routine tests and examinations showed no contraindications.
  • BMI≥28
  • Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery.

Exclusion Criteria:

  • A history of wasting diseases associated with malignancy and chemoradiotherapy that may interfere with wound healing
  • History of dermatosis
  • History of immune system diseases
  • History of blood diseases
  • Skin injury or defect at the back of the neck
  • Severe hypersensitivity
  • Cold, fever, trauma or other infections in the week before surgery
  • Infectious disease
  • Psychosis could not cooperate with follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Preoperative
Experimental: postoperative (3 months)
Procedure: posterior cervical surgery
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.
Experimental: postoperative (2 weeks)
Procedure: posterior cervical surgery
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.
Experimental: postoperative (4 weeks)
Procedure: posterior cervical surgery
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
JOA score change
Time Frame: 3 months after surgery
JOA score is used to assess the function of spinal cord which is in the form of questionnaires. Postoperative improvement rate = ((postoperative score - preoperative score)/ (17- preoperative score)) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: cure when the improvement rate is 100%, effective when the improvement rate is greater than 60%, effective when 25-60%, and ineffective when less than 25%.
3 months after surgery
NDI score change
Time Frame: 3 months after surgery
NDI score is used to assess the disorder of spinal cord which is in the form of questionnaires. Postoperative improvement rate = (total score)/ (numbers of programme X5) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: the improvement rate when 60%-80% means extremely severe dysfunction, when 40%-60% means severe dysfunction, when 20-40% means moderate dysfunction, and when less than 20% means mild dysfunction.
3 months after surgery
VAS score change
Time Frame: 3 months after surgery
A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound infection
Time Frame: 2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
The presence of wound infection was confirmed through the assessment of the patient's white blood cell count, erythrocyte sedimentation rate, C-reactive protein levels and other relevant biochemical markers. Additionally, signs such as erythema, edema, warmth, tenderness and other related symptoms should be evaluated to determine the presence of wound infection.
2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
wound dehiscence
Time Frame: 2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
The assessment of wound dehiscence primarily relied on the identification of suture rupture within the wound site through direct visualization.
2 weeks after surgery, 4 weeks after surgery, 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232136-F-1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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