Researching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Preoperative
|
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| Experimental: postoperative (2 weeks)
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Procedure: posterior cervical surgery
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.
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| Experimental: postoperative (4 weeks)
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Procedure: posterior cervical surgery
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.
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| Experimental: postoperative (3 months)
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Procedure: posterior cervical surgery
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.
|
Outcome Measures
Primary Outcome Measures
- JOA score change [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%.
- NDI score change [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.
- VAS score change [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.
Secondary Outcome Measures
- wound infection [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.
- wound dehiscence [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Preoperative routine tests and examinations showed no contraindications.
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BMI≥28
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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:
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A history of wasting diseases associated with malignancy and chemoradiotherapy that may interfere with wound healing
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History of dermatosis
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History of immune system diseases
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History of blood diseases
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Skin injury or defect at the back of the neck
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Severe hypersensitivity
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Cold, fever, trauma or other infections in the week before surgery
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Infectious disease
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Psychosis could not cooperate with follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jia Yanyan | Xi'an | Shannxi Province | China | 710034 |
Sponsors and Collaborators
- Xijing Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
- Sarsam OM, Dunning J, Pochulu B, Baste JM. Robot-assisted bronchoplasty using continuous barbed sutures. J Vis Surg. 2018 Jan 4;4:3. doi: 10.21037/jovs.2017.12.14. eCollection 2018.
- Yang S, Qi-Heng T, Yi-Xin Z. Comparison of Standard Suture vs Barbed Suture for Closing the Porcine Knee Joint: Evaluation of Biomechanical Integrity and Permeability. J Arthroplasty. 2018 Mar;33(3):903-907. doi: 10.1016/j.arth.2017.10.008. Epub 2017 Oct 10.
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