Back to resultsResearching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
Primary Purpose
Cervical Spinal Stenosis, Posterior Cervical Spine Surgery, Barbed Suture
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
posterior cervical surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spinal Stenosis
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
Sites / Locations
- Jia YanyanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Preoperative
postoperative (2 weeks)
postoperative (4 weeks)
postoperative (3 months)
Arm Description
Outcomes
Primary Outcome Measures
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%.
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.
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.
Secondary Outcome Measures
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.
wound dehiscence
The assessment of wound dehiscence primarily relied on the identification of suture rupture within the wound site through direct visualization.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05895968
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Stenosis, Posterior Cervical Spine Surgery, Barbed Suture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative
Arm Type
No Intervention
Arm Title
postoperative (2 weeks)
Arm Type
Experimental
Arm Title
postoperative (4 weeks)
Arm Type
Experimental
Arm Title
postoperative (3 months)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
posterior cervical surgery
Intervention Description
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.
Primary Outcome Measure Information:
Title
JOA score change
Description
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%.
Time Frame
3 months after surgery
Title
NDI score change
Description
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.
Time Frame
3 months after surgery
Title
VAS score change
Description
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.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
wound infection
Description
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.
Time Frame
2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
Title
wound dehiscence
Description
The assessment of wound dehiscence primarily relied on the identification of suture rupture within the wound site through direct visualization.
Time Frame
2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanyan Jia
Phone
15902984776
Email
14556263@qq.com
Facility Information:
Facility Name
Jia Yanyan
City
Xi'an
State/Province
Shannxi Province
ZIP/Postal Code
710034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Jia
Phone
15902984776
Email
14556263@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18619922
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.
Results Reference
background
PubMed Identifier
29445589
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.
Results Reference
background
PubMed Identifier
29103781
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.
Results Reference
background
PubMed Identifier
28089469
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.
Results Reference
result
PubMed Identifier
26819279
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.
Results Reference
result
Learn more about this trial
Researching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
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