Using barb suture in obese patients for cervical spine surgery
A Controlled Clinical Study on the Safety and Effectiveness of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
NA · Xijing Hospital · NCT05895968
This study is testing whether using special barb sutures during neck surgery can help obese patients recover better and have fewer problems after their operation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 28 Years to 85 Years |
| Sex | All |
| Sponsor | Xijing Hospital (other) |
| Locations | 1 site (Xi'an, Shannxi Province) |
| Trial ID | NCT05895968 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of using barb sutures during posterior cervical surgery specifically for obese patients. It is a single-center exploratory study that aims to provide evidence for the broader application of this technique in surgical procedures involving cervical spinal stenosis. The study focuses on patients with specific MRI-confirmed conditions and assesses their outcomes post-surgery. The goal is to determine if barb sutures can improve surgical results in this patient population.
Who should consider this trial
Good fit: Ideal candidates are obese patients with cervical spinal stenosis or myelopathy confirmed by MRI, specifically those with a BMI of 28 or higher.
Not a fit: Patients with a history of conditions that impair wound healing or those with active infections or severe skin issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical outcomes and recovery for obese patients undergoing cervical spine surgery.
How similar studies have performed: While the use of barb sutures in surgery is gaining interest, this specific application in obese patients undergoing posterior cervical surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Xi'an, Shannxi Province
- Jia Yanyan — Xi'an, Shannxi Province, China (RECRUITING)
Study contacts
- Study coordinator: Yanyan Jia
- Email: 14556263@qq.com
- Phone: 15902984776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Spinal Stenosis, Posterior Cervical Spine Surgery, Barbed Suture