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

NCT05895968 | Recruiting

• 1 other identifier: KY20232136-F-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spinal Stenosis; Posterior Cervical Spine Surgery; Barbed Suture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• wound infection

  2 weeks after surgery, 4 weeks after surgery, 3 months after surgery

• wound dehiscence

  2 weeks after surgery, 4 weeks after surgery, 3 months after surgery

Study Arms (4)

Preoperative

NO INTERVENTION

postoperative (2 weeks)

EXPERIMENTAL

Procedure: posterior cervical surgery

postoperative (4 weeks)

EXPERIMENTAL

Procedure: posterior cervical surgery

postoperative (3 months)

EXPERIMENTAL

Procedure: posterior cervical surgery

Interventions

posterior cervical surgery PROCEDURE

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

postoperative (2 weeks); postoperative (3 months); postoperative (4 weeks)

Eligibility Criteria

• Age: 28 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Jia Yanyan

Xi'an, Shannxi Province, 710034, China

RECRUITING

Related 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.

  PMID: 28089469 BACKGROUND

• 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 Oncol. 2016 Apr;46(4):329-35. doi: 10.1093/jjco/hyv212. Epub 2016 Jan 26.

  PMID: 26819279 BACKGROUND

• 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.

  PMID: 18619922 BACKGROUND

• 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.

  PMID: 29445589 BACKGROUND

• 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.

  PMID: 29103781 BACKGROUND

Central Study Contacts

Yanyan Jia

CONTACT

15902984776; 14556263@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 9, 2023
• Study Start: January 1, 2023
• Primary Completion: January 31, 2023
• Study Completion: December 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)