Researching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-85
SponsorXijing Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
posterior cervical surgery
Procedure/SurgeryThe patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: PreoperativeNo intervention 0 interventions
Group B: postoperative (2 weeks)Experimental treatment 1 intervention
Group C: postoperative (4 weeks)Experimental treatment 1 intervention
Group D: postoperative (3 months)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
3 months after surgery2
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.
Time frame
3 months after surgery3
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.
Time frame
3 months after surgerySecondary outcomes
1
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.
Time frame
2 weeks after surgery, 4 weeks after surgery, 3 months after surgery2
wound dehiscence
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 surgerySponsors and contacts
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Source ClinicalTrials.gov