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NCT Number: NCT05895968

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

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.

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Key information

Age range

28 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jia Yanyan

Xi'an, Shannxi Province, 710034, China

Location status: Recruiting

Location contact

Yanyan Jia

CONTACT

[email protected]

15902984776

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. JOA score change

    Time frame: 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%.

  2. NDI score change

    Time frame: 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.

  3. VAS score change

    Time frame: 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 outcomes

  1. wound infection

    Time frame: 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.

  2. wound dehiscence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanyan Jia

CONTACT

[email protected]

15902984776

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

A Controlled Clinical Study on the Safety and Effectiveness of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Jun 9, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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