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Recruiting NCT05895968

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

No phase Interventional Cervical Spinal Stenosis Posterior Cervical Spine Surgery Barbed Suture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: posterior cervical surgery.
Who it may be relevant to
Registry conditions: Cervical Spinal Stenosis, Posterior Cervical Spine Surgery, Barbed Suture. Basic parameters: 28 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • JOA score change [Time frame: 3 months after surgery]
  • NDI score change [Time frame: 3 months after surgery]
  • VAS score change [Time frame: 3 months after surgery]
Secondary outcome measures (2)
  • wound infection [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Jia Yanyan — Xi'an

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. PMID 18619922
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT05895968 · KY20232136-F-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗