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

Cervical Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895968
• Other study ID #: KY20232136-F-1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Xijing Hospital
• Contact: Yanyan Jia
• Phone: 15902984776
• Email: 14556263[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• posterior cervical surgery
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.

Locations

Country	Name	City	State
China	Jia Yanyan	Xi'an	Shannxi Province

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Chan VWK, Chan PK, Chiu KY, Yan CH, Ng FY. Does Barbed Suture Lower Cost and Improve Outcome in Total Knee Arthroplasty? A Randomized Controlled Trial. J Arthroplasty. 2017 May;32(5):1474-1477. doi: 10.1016/j.arth.2016.12.015. Epub 2016 Dec 21. — View Citation

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. — View Citation

Lee SW, Kawai M, Tashiro K, Nomura E, Tokuhara T, Kawashima S, Tanaka R, Uchiyama K. Laparoscopic gastrointestinal anastomoses using knotless barbed absorbable sutures are safe and reproducible: a single-center experience with 242 patients. Jpn J Clin Onc — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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