Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT02992951
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2016-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DACC in the REduction of Surgical Site INfection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 718}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2016-12-12', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SWAT 1 Validation Acceptability', 'timeFrame': '30 and 37 days', 'description': 'Response rates to measure at 30 and 37 days'}, {'measure': 'SWAT 1 Validation reliability', 'timeFrame': '30 and 37 days', 'description': 'Inter and intra rater reliability'}, {'measure': 'SWAT 1 Validation Validity', 'timeFrame': '30 days', 'description': 'Sensitivity, specificity, ROC analysis, AUC'}, {'measure': 'SWAT 2 Hair Removal Feasibility', 'timeFrame': '30 days', 'description': 'Safety/adverse events'}, {'measure': 'Carbon Footprint Model Development', 'timeFrame': '3 months', 'description': 'Healthcare resource use data, consumable item weights'}], 'primaryOutcomes': [{'measure': '30 day infection rate', 'timeFrame': '30 days', 'description': 'Surgical Site Infection at 30 days post-op'}], 'secondaryOutcomes': [{'measure': '3 month infection rate', 'timeFrame': '3 months', 'description': 'Surgical Site Infection at 3 months post-op (implant patients only)'}, {'measure': 'Quality of Life (SF-36 V2)', 'timeFrame': '30 days, 3 months', 'description': 'Score ranging from 0-100, higher values indicating better health'}, {'measure': 'Quality of Life (EQ-5D-3L)', 'timeFrame': '30 days, 3 months', 'description': 'Score ranging from 5-15, higher scores indicating worse health'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': '30-day mortality'}, {'measure': 'Bluebelle wound healing questionnaire', 'timeFrame': 'Days 30 and 37', 'description': 'Score ranging 0-41, higher values indicating infection'}, {'measure': 'Carbon Footprint Analysis', 'timeFrame': '3 months', 'description': 'Healthcare resource use data'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infection', 'Surgical Site Infection', 'Dialkylcarbamoylchloride'], 'conditions': ['Infection, Bacterial', 'Wound Infection', 'Wound Infection, Surgical', 'Surgical Incision', 'Surgical Wound']}, 'referencesModule': {'references': [{'pmid': '30680225', 'type': 'BACKGROUND', 'citation': 'Totty JP, Harwood AE, Cai PL, Hitchman LH, Smith GE, Chetter IC. Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial. Pilot Feasibility Stud. 2019 Jan 18;5:11. doi: 10.1186/s40814-019-0400-2. eCollection 2019.'}, {'pmid': '40260835', 'type': 'DERIVED', 'citation': 'Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.'}], 'seeAlsoLinks': [{'url': 'https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0400-2', 'label': 'Abstract Link'}]}, 'descriptionModule': {'briefSummary': 'Surgical site infection is an infection at a place in the body where surgery has taken place, and has been reported in around 5% of people undergoing an operation. In vascular surgery, infection rates are as high as 30%. Methods to reduce this rate of infection should be investigated thoroughly for their effectiveness and cost-effectiveness.\n\nThe investigators aim to conduct a research trial examining one such method. Leukomed Sorbact is a wound dressing coated with a chemical (DACC) derived from spider-silk that interacts with, and binds bacteria, causing them to be mechanically removed from a wound when the dressing is changed. The trial aims to compare the effectiveness of this dressing to a standard, non-coated dressing, in the reduction of surgical site infection.\n\n718 patients from a number of centres across the UK will be recruited to this study. Adult patients who are having a vascular surgery operation will be approached for entry into the trial. The trial will be explained to them, as well as an explanation that participation is voluntary and their operation or other aspects of their care will not be impacted in any way should participants not wish to participate.\n\nParticipants will be randomised by computer into one of two groups - one group whose wounds are dressed with Leukomed Sorbact, and the other whose wounds are dressed with a standard dressing. Patients will be followed up at 30 days post-operatively. At the follow up, their wounds will be inspected for infection, and participants will be asked to complete short questionnaires measuring quality of life. Quality of life will also be assessed at 3 months post surgery.\n\nThe trial will aim to answer a number of questions, with the primary question being does a DACC coated dressing applied after an operation reduce the risk of an infection at the surgery site? It will also ask whether this treatment is cost-effective and whether it promotes satisfactory healing and evaluate the overall carbon footprint impact of each intervention.\n\nStudies Within a Trial will be conducted to validate a remote diagnostic measure for detecting surgical site infection using wound images and the Bluebelle Wound Healing Questionnaire, evaluate feasibility of novel hair removal methods such as epilation and waxing, carbon footprint modelling within randomised controlled trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible for inclusion in the study the participants must meet the following criteria:\n\n* Adults ≥18 yrs undergoing clean or clean-contaminated lower limb vascular surgery, with wounds closed by primary intention.\n* Able to understand the Patient Information Sheet and supplementary materials and capable and willing to give informed consent and follow the protocol requirements (including attending all follow-up visits and completing written questionnaires).\n\nExclusion Criteria:\n\nPatients will not be included in the study if they meet any of the following exclusion criteria:\n\n* Patients on antibiotics for other conditions at the time of surgery or in the follow up period.\n* Patients undergoing any procedure that does not include lower limb incisions.\n* Allergies to any component of either the DACC-coated dressing or the control dressing.\n* Inability to give informed consent due to incapacity (as defined by the MCA 2005)\n* Aged under 18 years at the time of recruitment\n* Use of investigational drug/device therapy within preceding 4 weeks that may interfere with this study.'}, 'identificationModule': {'nctId': 'NCT02992951', 'acronym': 'DRESSINg', 'briefTitle': 'DACC in the REduction of Surgical Site INfection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'A Randomised Controlled Trial to Assess the Clinical and Cost Effectiveness of Dialkylcarbamoylchloride (DACC) Coated Post-operative Dressings Versus Standard Care in the Prevention of Surgical Site Infection in Clean or Clean-contaminated, Vascular Surgery.', 'orgStudyIdInfo': {'id': 'R2034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DACC-Coated Post-Operative Dressing', 'description': 'DACC-Coated Post-Operative Dressing', 'interventionNames': ['Device: DACC-Coated Post Operative Dressing']}, {'type': 'NO_INTERVENTION', 'label': 'Non-DACC coated Occlusive Post-operative Film Dressing', 'description': 'Non-DACC coated Occlusive Post-operative Film Dressing'}], 'interventions': [{'name': 'DACC-Coated Post Operative Dressing', 'type': 'DEVICE', 'otherNames': ['Leukomed Sorbact'], 'description': 'Leukomed Sorbact is a non-active coated wound dressing, containing Dialkylcarbomoylchloride. This is a bacteria-binding compound that adheres bacteria via hydrophobic interaction and removes them from the wound bed at dressing change.', 'armGroupLabels': ['DACC-Coated Post-Operative Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU3 2JZ', 'city': 'Hull', 'state': 'East Riding Of Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ross Lathan, MbChB', 'role': 'CONTACT', 'email': 'ross.lathan2@nhs.net', 'phone': '01482674643'}, {'name': 'George E Smith, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ian C Chetter, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joshua P Totty, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paris L Cai, MbChB', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ross Lathan, MbChB', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}], 'centralContacts': [{'name': 'Ross Lathan, MBChB', 'role': 'CONTACT', 'email': 'ross.lathan2@nhs.net', 'phone': '+44 01482674643'}, {'name': 'Judith Long', 'role': 'CONTACT', 'email': 'judith.long3@nhs.net', 'phone': '+44 01482 675784'}], 'overallOfficials': [{'name': 'George Smith, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hull University Teaching Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Hull', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}