Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05895968

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age28 Years to 85 Years

SexAll

Healthy volunteersNot accepted

ConditionCervical Spinal Stenosis, Posterior Cervical Spine Surgery, Barbed Suture

Full registry 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

Treatments and study arms

posterior cervical surgery

Procedure

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

Primary outcomes

JOA score change3 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 change3 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 change3 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.

Study locations

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Jia Yanyan🇨🇳 Xi'an, Shannxi Province, China

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Yanyan JiaContact

Email · Call 15902984776