Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-27 @ 5:09 AM
Study NCT ID:
NCT03141502
Status:
UNKNOWN
Last Update Posted:
2017-05-05
First Post:
2017-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The New Skin Stretching Device for Treatment of Limb Tension Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005597', 'term': 'Fractures, Open'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016038', 'term': 'Skin Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D062109', 'term': 'Dermatologic Surgical Procedures'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-05-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change of surface area of the scar', 'timeFrame': 'change from surgery at 6 months', 'description': 'it is performed by tracing the area of the scar directly onto non-stretchable transparent sterile sheets. then digitized and analyzed by software.'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'during surgery', 'description': 'refers to the time required for the application of skin stretching device or skin grafting'}, {'measure': 'Wound site and wound healing time', 'timeFrame': 'from surgery to 6 months', 'description': 'record the site of the operation, and the time from the beginning of surgery to the complete healing of the wound.'}, {'measure': 'Vancouver scar scale (VSS)', 'timeFrame': '3 and 6 months after surgery', 'description': 'evaluate the scar scale by VSS'}, {'measure': 'scar vascularization index', 'timeFrame': '3 and 6 months after surgery', 'description': 'use photometric analyzer to measure its erythema index, assessing its angiogenesis and vascularization'}, {'measure': 'scar pigmentation index', 'timeFrame': '3 and 6 months after surgery', 'description': 'use photometric analyzer to measure its melanin index, assessing its pigmentation'}, {'measure': 'collagen fibers arrangement under electron microscopy', 'timeFrame': 'surgery and 6 months after surgery', 'description': 'use the drilling device to take the skin tissue of the diameter of 3mm for histological examination, measuring the collagen fibers arrangement by Electron microscopy'}, {'measure': 'dermal matrix arrangement under electron microscopy', 'timeFrame': 'surgery and 6 months after surgery', 'description': 'use the drilling device to take the skin tissue of the diameter of 3mm for histological examination, measuring the dermal matrix arrangement by Electron microscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tension wound', 'skin stretching device', 'skin grafting'], 'conditions': ['Trauma', 'Fractures, Open', 'Wounds and Injuries', 'Skin Expander']}, 'referencesModule': {'references': [{'pmid': '24746282', 'type': 'BACKGROUND', 'citation': 'Verhaegen PD, Bloemen MC, van der Wal MB, Vloemans AF, Tempelman FR, Beerthuizen GI, van Zuijlen PP. Skin stretching for primary closure of acute burn wounds. Burns. 2014 Dec;40(8):1727-37. doi: 10.1016/j.burns.2014.03.014. Epub 2014 Apr 16.'}, {'pmid': '21228739', 'type': 'BACKGROUND', 'citation': 'Verhaegen PDHM, van Trier AJM, Jongen SJM, Vlig M, Nieuwenhuis MK, Middelkoop E, van Zuijlen PPM. Efficacy of skin stretching for burn scar excision: a multicenter randomized controlled trial. Plast Reconstr Surg. 2011 May;127(5):1958-1966. doi: 10.1097/PRS.0b013e31820cf4be.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial is performed to evaluate the effectiveness and safety of the Skin Stretching Device (SSD) on limb tension incision closure by comparing whether the differences in wounds area, wounds closure time and scar assessment between the SSD and the skin grafting are statistically significant.', 'detailedDescription': 'Design:\n\nThis study is a multicenter and randomized control study with the participation of 15 major national or regional central hospitals. And the whole sample size is set to be 100 patients.\n\nPatients who have been screened by inclusion and exclusion criteria will be randomly (non-transparent envelope) assigned to Skin Stretching Group (SS Group) or Skin Grafting Group (SG Group). Patients of both group will undergo surgical debridement for the same principle, while the Skin Stretching Device is used for the patients of SS Group for incision closure and the Skin Grafting is used for the patients of SG group for incision closure.\n\nOutcome evaluation:\n\nWound and scar evaluation during surgery, three and six months after surgery will include the following parameters:\n\n* surface area;\n* Vancouver scar scale (VSS)\n* vascularization and pigmentation;\n* dermal architecture. After 3 and 6 months patients will undergo a biopsy of the scar under local anesthesia. The experimental group, treated with the SSD will undergo one extra biopsy of the formerly stretched skin.\n\nSafety evaluation:\n\nDuring the trial, adverse events are observed and evaluated. Adverse reactions to clinical manifestations are followed and recorded till the symptoms disappear. The subject with serious adverse events shall withdraw from the study and be treated accordingly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Ageā„18 years old\n2. Tension incision that cannot be directly closed due to limb trauma or surgical debridement\n3. Incision that cannot be directly closed after the incision decompression for fascia compartment syndrome and ischemia and reperfusion injury\n4. Both sides of the incision skin suitable for skin stretching\n\nExclusion criteria:\n\n1. Age \\<18 years old\n2. Skin disease\n3. Keloid history\n4. Local or systemic use of hormones\n5. Systemic diseases: for example, diabetes, immunodeficiency disease, vascular disease and etc.\n6. Other poor general state to result in inability for trial;\n7. Mental illness.'}, 'identificationModule': {'nctId': 'NCT03141502', 'acronym': 'SSDRCT', 'briefTitle': 'The New Skin Stretching Device for Treatment of Limb Tension Wounds', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Dalian Medical University'}, 'officialTitle': 'The New Skin Stretching Device for Treatment of Limb Tension Wounds: A Multicenter Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'LCSY2017-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skin Stretching Device (SSD)', 'description': 'the wound is primarily closed by aid of the SSD after necessary surgical debridement.', 'interventionNames': ['Device: Skin stretching device (SSD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Skin Grafting (SG)', 'description': 'the wound is primarily closed by the technique of skin grafting after necessary surgical debridement.', 'interventionNames': ['Procedure: Skin grafting']}], 'interventions': [{'name': 'Skin stretching device (SSD)', 'type': 'DEVICE', 'description': 'By making use of skin viscoelasticity, the special metal crochet of SSD would be embedded in both sides skin of the wound. Multiple cycles of stretching and relaxing wound lead to extended skin, changing the high tension incision into a low tension incision and facilitating the direct suture.', 'armGroupLabels': ['Skin Stretching Device (SSD)']}, {'name': 'Skin grafting', 'type': 'PROCEDURE', 'description': 'the standard technique of skin grafting after wound preparation.', 'armGroupLabels': ['Skin Grafting (SG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116011', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'contacts': [{'name': 'Nuo Li', 'role': 'CONTACT', 'email': 'dyyykyb@163.com', 'phone': '86-0411-83635963', 'phoneExt': '3015'}, {'name': 'Yinan Wang', 'role': 'CONTACT', 'email': 'dyfyjwb@163.com', 'phone': '86-0411-83635963', 'phoneExt': '3037'}, {'name': 'Ming Lu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Deqiang Zhang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chongyang Fu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Junwei Junwei, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'the First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}], 'centralContacts': [{'name': 'Junwei Zong, MD', 'role': 'CONTACT', 'email': 'aweizone@163.com', 'phone': '86041183635963', 'phoneExt': '3131'}, {'name': 'Nuo Li', 'role': 'CONTACT', 'email': 'dyyykyb@163.com', 'phone': '86041183635963', 'phoneExt': '3015'}], 'overallOfficials': [{'name': 'Xin Tang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Dalian Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}