Barbed Suture, Cervical Spinal Stenosis, Posterior Cervical Spine Surgery
Conditions
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.
Interventions
PROCEDUREposterior cervical surgery
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.
Sponsors
Xijing Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| JOA score change | 3 months after surgery | 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 | 3 months after surgery | 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 | 3 months after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| wound infection | 2 weeks after surgery, 4 weeks after surgery, 3 months after surgery | 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 | 2 weeks after surgery, 4 weeks after surgery, 3 months after surgery | The assessment of wound dehiscence primarily relied on the identification of suture rupture within the wound site through direct visualization. |
Countries
China
Contacts
CONTACTYanyan Jia
Outcome results
None listed