Clinical trial NCT05895968: Researching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
Official title: A Controlled Clinical Study on the Safety and Effectiveness of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spinal Stenosis
Posterior Cervical Spine Surgery
Barbed Suture
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: JOA score change
timeFrame: 3 months after surgery
measure: NDI score change
timeFrame: 3 months after surgery
measure: VAS score change
timeFrame: 3 months after surgery
Secondary outcomes:
measure: wound infection
timeFrame: 2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
measure: wound dehiscence
timeFrame: 2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Jia Yanyan
state: Shannxi Province
Study officials:
References:
citation: 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.
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 Oncol. 2016 Apr;46(4):329-35. doi: 10.1093/jjco/hyv212. Epub 2016 Jan 26.
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.
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.
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.