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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Spinal Stenosis, Posterior Cervical Spine Surgery, Barbed Suture

Intervention / Treatment
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* Procedure: posterior cervical surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| JOA score change | 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 | 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 | 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 | 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 | 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 |