Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-27 @ 7:27 PM
Study NCT ID:
NCT05895968
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2023-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Researching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-06', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'JOA score change', 'timeFrame': '3 months after surgery', 'description': '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%.'}, {'measure': 'NDI score change', 'timeFrame': '3 months after surgery', 'description': '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.'}, {'measure': 'VAS score change', 'timeFrame': '3 months after surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'wound infection', 'timeFrame': '2 weeks after surgery, 4 weeks after surgery, 3 months after surgery', 'description': "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."}, {'measure': 'wound dehiscence', 'timeFrame': '2 weeks after surgery, 4 weeks after surgery, 3 months after surgery', 'description': 'The assessment of wound dehiscence primarily relied on the identification of suture rupture within the wound site through direct visualization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Spinal Stenosis', 'Posterior Cervical Spine Surgery', 'Barbed Suture']}, 'referencesModule': {'references': [{'pmid': '28089469', 'type': 'BACKGROUND', 'citation': 'Chan VWK, Chan PK, Chiu KY, Yan CH, Ng FY. Does Barbed Suture Lower Cost and Improve Outcome in Total Knee Arthroplasty? A Randomized Controlled Trial. J Arthroplasty. 2017 May;32(5):1474-1477. doi: 10.1016/j.arth.2016.12.015. Epub 2016 Dec 21.'}, {'pmid': '26819279', 'type': 'BACKGROUND', 'citation': 'Lee SW, Kawai M, Tashiro K, Nomura E, Tokuhara T, Kawashima S, Tanaka R, Uchiyama K. Laparoscopic gastrointestinal anastomoses using knotless barbed absorbable sutures are safe and reproducible: a single-center experience with 242 patients. Jpn J Clin Oncol. 2016 Apr;46(4):329-35. doi: 10.1093/jjco/hyv212. Epub 2016 Jan 26.'}, {'pmid': '18619922', 'type': 'BACKGROUND', 'citation': 'Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.'}, {'pmid': '29445589', 'type': 'BACKGROUND', 'citation': 'Sarsam OM, Dunning J, Pochulu B, Baste JM. Robot-assisted bronchoplasty using continuous barbed sutures. J Vis Surg. 2018 Jan 4;4:3. doi: 10.21037/jovs.2017.12.14. eCollection 2018.'}, {'pmid': '29103781', 'type': 'BACKGROUND', 'citation': 'Yang S, Qi-Heng T, Yi-Xin Z. Comparison of Standard Suture vs Barbed Suture for Closing the Porcine Knee Joint: Evaluation of Biomechanical Integrity and Permeability. J Arthroplasty. 2018 Mar;33(3):903-907. doi: 10.1016/j.arth.2017.10.008. Epub 2017 Oct 10.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '28 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Preoperative routine tests and examinations showed no contraindications.\n* BMI≥28\n* Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery.\n\nExclusion Criteria:\n\n* A history of wasting diseases associated with malignancy and chemoradiotherapy that may interfere with wound healing\n* History of dermatosis\n* History of immune system diseases\n* History of blood diseases\n* Skin injury or defect at the back of the neck\n* Severe hypersensitivity\n* Cold, fever, trauma or other infections in the week before surgery\n* Infectious disease\n* Psychosis could not cooperate with follow-up'}, 'identificationModule': {'nctId': 'NCT05895968', 'briefTitle': 'Researching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'A Controlled Clinical Study on the Safety and Effectiveness of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery', 'orgStudyIdInfo': {'id': 'KY20232136-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Preoperative'}, {'type': 'EXPERIMENTAL', 'label': 'postoperative (2 weeks)', 'interventionNames': ['Procedure: posterior cervical surgery']}, {'type': 'EXPERIMENTAL', 'label': 'postoperative (4 weeks)', 'interventionNames': ['Procedure: posterior cervical surgery']}, {'type': 'EXPERIMENTAL', 'label': 'postoperative (3 months)', 'interventionNames': ['Procedure: posterior cervical surgery']}], 'interventions': [{'name': 'posterior cervical surgery', 'type': 'PROCEDURE', 'description': 'The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.', 'armGroupLabels': ['postoperative (2 weeks)', 'postoperative (3 months)', 'postoperative (4 weeks)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710034', 'city': "Xi'an", 'state': 'Shannxi Province', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanyan Jia', 'role': 'CONTACT', 'email': '14556263@qq.com', 'phone': '15902984776'}], 'facility': 'Jia Yanyan', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Yanyan Jia', 'role': 'CONTACT', 'email': '14556263@qq.com', 'phone': '15902984776'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}