Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 12:25 PM
Study NCT ID:
NCT05727995
Status:
UNKNOWN
Last Update Posted:
2023-02-14
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The statistician generates the random list and the outcome assessors guarantee the blinding procedure.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': "After checking the patients' eligibility they will be blindly randomized in the arm allocation (allocation 1:1)."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leg wound assessment', 'timeFrame': 'At baseline (post-surgery)', 'description': 'This outcome will be assessed as a categorial variable: a) no complication; b) dehiscence; c) signs of superficial infections. The operative assessment consists of a daily evaluation of the leg wound after the surgery and follow-up assessments.'}, {'measure': 'Leg wound assessment', 'timeFrame': 'At 15 days post-surgery', 'description': 'This outcome will be assessed as a categorial variable: a) no complication; b) dehiscence; c) signs of superficial infections. The operative assessment consists of a daily evaluation of the leg wound after the surgery and follow-up assessments.'}, {'measure': 'Leg wound assessment', 'timeFrame': 'At one month post-surgery', 'description': 'This outcome will be assessed as a categorial variable: a) no complication; b) dehiscence; c) signs of superficial infections. The operative assessment consists of a daily evaluation of the leg wound after the surgery and follow-up assessments.'}], 'secondaryOutcomes': [{'measure': 'General in hospital complications', 'timeFrame': 'Follow-up 15 days', 'description': 'General In-hospital clinical complications (yes versus no; if yes, which complications?)'}, {'measure': 'Days of acute hospitalization', 'timeFrame': 'Follow-up 30 days', 'description': 'Length of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['negative pressure wound therapy'], 'conditions': ['Wound of Skin']}, 'descriptionModule': {'briefSummary': 'The role of prophylactic negative pressure wound therapy (NPWT) is promising in reducing wound-related complications. However, the prophylactic use of NPWT in reducing wound complications in patients who underwent conventional open harvesting of the great saphenous vein has been under-investigated compering with other surgical approaches.\n\nTherefore, this study aims to assess the effect size of the prophylactic NPWT in preventing wound dehiscence in high-risk patients who underwent conventional open harvesting of the great saphenous vein as a conduit for coronary artery bypass.', 'detailedDescription': 'The study design is a prospective, randomized, controlled, and monocentric trial. The primary endpoint is given by the reduction of wound dehiscence as a dichotomic outcome (yes versus no).\n\nMore precisely, in the experimental group, we will use the proposed device PICO7 (NPWT); this device is certificate CE. PICO consists of a single-use (i.e., completely disposable) NPWT unit, canister, and dressing that are designed for application over clean, closed, sutured, or stapled incisions in a simple peel-and-place process. Instead, in the control group, patients will receive standard care.\n\nFinally, patients eligible to be enrolled in this study will be blindly randomized using for the arm allocation (allocation 1:1). Randomization should take place as soon as possible after consent. Patients will be randomized on a 1:1 basis to receive either dressing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (aged ≥ 50 years)\n* Diagnosis of Diabetes (both type 1 and 2) as comorbidity with anamnesis during the last year of poor glycemic control (HbA1C \\>7.5%)\n* BMI ≥ 25 Kg/m2\n\nExclusion Criteria:\n\n* Cognitive impairment\n* Anamnesis of non-heling wounds\n* Wagner grade 2-5 foot wound\n* Osteomyelitis\n* Pregnancy\n* Contraindication to use PICO7 described previously.'}, 'identificationModule': {'nctId': 'NCT05727995', 'acronym': 'EFESO', 'briefTitle': 'Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT) on Prevention for Complications After Open Saphenous Vein Harvest in Cardiac Surgery (EFESO Protocol).', 'orgStudyIdInfo': {'id': '126/int/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'The dressing is a polyurethane film with acrylic adhesive that adheres the dressing to the skin surrounding the incision and a polyurethane shell that encapsulates the foam bolster and interface layer, providing a closed system. The PICO pump maintains negative pressure wound therapy (NPWT) at 80mmHg (nominal) +/- 20mmHg to the wound surface. Exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film. PICO is intended for use in wound sizes (surface area x depth) up to 400 cm3, which are considered to be low to moderately exuding. The kit is intended to be used for 7 days on low-exuding wounds and 6 days on moderately exuding wounds. The therapy duration of the kit may be less than indicated if a clinical practice or other factors, such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes.', 'interventionNames': ['Device: PICO7']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Patients in the control arm will receive a usual care dressing using absorbent cotton pads placed in contact with the wound. Dressings will be applied directly to the wound surface to protect the wound surface environment and the wound bed. Dressing chances are scheduled every 48h.', 'interventionNames': ['Other: usual care dressing']}], 'interventions': [{'name': 'PICO7', 'type': 'DEVICE', 'description': 'The use of PICO is contraindicated in the presence of:\n\n* Patients with malignancy in the wound bed or margins of the wound\n* Previously confirmed and untreated osteomyelitis\n* Nonenteric and unexplored fistulas\n* Necrotic tissue with eschar present\n* Exposed arteries, veins, nerves or organs\n* Exposed anastomotic sites\n* Emergency airway aspiration\n* Pleural, mediastinal or chest tube drainage\n* Surgical suction.', 'armGroupLabels': ['Experimental group']}, {'name': 'usual care dressing', 'type': 'OTHER', 'description': 'usual care dressing', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Castiello', 'role': 'CONTACT', 'email': 'gianluca.castiello@grupposandonato.it', 'phone': '3474834455'}], 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gianluca Castiello', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}