Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT06312267
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Wound Infections Using Bioelectric Wound Dressings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Total of 20 patients will be identified and divided in two groups (control and experimental group). 10 of the patients undergo surgery using current ERAS protocol standard of care skin cleaning preparation. The other 10 patients skin prep will be substituted with the Bioelectrical dressing preoperatively and post-operative.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative bacterial count', 'timeFrame': '4 total biopsies will be collected. (3 days before surgery, surgery day pre incision, immediately post-surgery and 3 days post-surgery)', 'description': 'Skin biopsies will be collected and analyzed for bacterial counts'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Surgery outcomes', 'Bioelectric dressing,'], 'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '30426190', 'type': 'BACKGROUND', 'citation': 'Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.'}, {'pmid': '30195951', 'type': 'BACKGROUND', 'citation': 'Cooke CL, Greene RS, van Eck CF, Uquilas C, Limpisvasti O. Bioelectric Silver-Zinc Dressing Equally Effective to Chlorhexidine in Reducing Skin Bacterial Load in Healthy Volunteers. Arthroscopy. 2018 Oct;34(10):2886-2891. doi: 10.1016/j.arthro.2018.05.046. Epub 2018 Sep 5.'}, {'pmid': '27168571', 'type': 'BACKGROUND', 'citation': 'Kim H, Park S, Housler G, Marcel V, Cross S, Izadjoo M. An Overview of the Efficacy of a Next Generation Electroceutical Wound Care Device. Mil Med. 2016 May;181(5 Suppl):184-90. doi: 10.7205/MILMED-D-15-00157.'}, {'pmid': '25803639', 'type': 'BACKGROUND', 'citation': 'Banerjee J, Das Ghatak P, Roy S, Khanna S, Hemann C, Deng B, Das A, Zweier JL, Wozniak D, Sen CK. Silver-zinc redox-coupled electroceutical wound dressing disrupts bacterial biofilm. PLoS One. 2015 Mar 24;10(3):e0119531. doi: 10.1371/journal.pone.0119531. eCollection 2015.'}, {'pmid': '24595050', 'type': 'BACKGROUND', 'citation': 'Banerjee J, Das Ghatak P, Roy S, Khanna S, Sequin EK, Bellman K, Dickinson BC, Suri P, Subramaniam VV, Chang CJ, Sen CK. Improvement of human keratinocyte migration by a redox active bioelectric dressing. PLoS One. 2014 Mar 3;9(3):e89239. doi: 10.1371/journal.pone.0089239. eCollection 2014.'}, {'pmid': '29099398', 'type': 'BACKGROUND', 'citation': 'Barki KG, Das A, Dixith S, Ghatak PD, Mathew-Steiner S, Schwab E, Khanna S, Wozniak DJ, Roy S, Sen CK. Electric Field Based Dressing Disrupts Mixed-Species Bacterial Biofilm Infection and Restores Functional Wound Healing. Ann Surg. 2019 Apr;269(4):756-766. doi: 10.1097/SLA.0000000000002504.'}, {'pmid': '24627730', 'type': 'BACKGROUND', 'citation': 'Kim H, Makin I, Skiba J, Ho A, Housler G, Stojadinovic A, Izadjoo M. Antibacterial efficacy testing of a bioelectric wound dressing against clinical wound pathogens. Open Microbiol J. 2014 Feb 21;8:15-21. doi: 10.2174/1874285801408010015. eCollection 2014.'}, {'pmid': '25647504', 'type': 'BACKGROUND', 'citation': 'Kim H, Izadjoo MJ. Antibiofilm efficacy evaluation of a bioelectric dressing in mono- and multi-species biofilms. J Wound Care. 2015 Feb;24 Suppl 2:S10-4. doi: 10.12968/jowc.2015.24.Sup2.S10.'}, {'pmid': '32648141', 'type': 'BACKGROUND', 'citation': 'Kulkarni N, Arulampalam T. Laparoscopic surgery reduces the incidence of surgical site infections compared to the open approach for colorectal procedures: a meta-analysis. Tech Coloproctol. 2020 Oct;24(10):1017-1024. doi: 10.1007/s10151-020-02293-8. Epub 2020 Jul 9.'}, {'pmid': '21768407', 'type': 'RESULT', 'citation': 'Hubner M, Diana M, Zanetti G, Eisenring MC, Demartines N, Troillet N. Surgical site infections in colon surgery: the patient, the procedure, the hospital, and the surgeon. Arch Surg. 2011 Nov;146(11):1240-5. doi: 10.1001/archsurg.2011.176. Epub 2011 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation.', 'detailedDescription': 'The standard of care for enhance recovery after surgery (ERAS) protocol uses chlorhexidine alcohol base prep as the way to clean the skin preoperatively to decrease bacterial flora before sterile prep at the OR.\n\nUnder ERAS protocol there is no recommendations on any post-operative dressing. Biolelectric wound dressing has been introduced, used and proof to decrease wound infection in orthopedic extremity clean surgery for years.\n\nThe purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elective diverticular, benign polyp, or colon cancer resection\n2. Age 18-90 years old\n3. All patients must receive some kind of bowel prep (SU- prep, pills, Go-Lytely, milk of magnesia, etc.…)\n4. Must be off antibiotics for more than 2 weeks before surgery\n5. Surgery must be laparoscopic, hand assisted or Robotic\n6. Skin will be closed in layers and subcuticular interrupted fashion\n7. Just one dose of preoperative antibiotics (Invanz or equivalent if patient is allergic)\n8. Patients will have a primary anastomosis, no colostomy.\n9. Patient must be compliant with dressing care\n10. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Active infections before surgery -example: Intra-abdominal abscess not drained or actively on antibiotics on the day of surgery, skin infections\n2. Inability to take intestinal bowel preparation\n3. HgbA1c \\>8\n4. BMI \\>40\n5. Immunosuppression\n6. Need of steroid stress dose pre-op\n7. Patient receiving active chemotherapy\n8. Need of stoma (end ostomies after resection protective stoma included)\n9. Need of blood transfusion during surgery\n10. Use of irrigation with antibiotics or IRRISEPTR during surgery\n11. Any standard contraindication to anesthesia and/or surgery\n12. Pregnancy or lactating women\n13. Inability to provide informed consent\n14. Inability to follow instructions for dressing care\n15. Sensitivity or allergy to silver or zinc'}, 'identificationModule': {'nctId': 'NCT06312267', 'acronym': 'JumpStart', 'briefTitle': 'Reducing Wound Infections Using Bioelectric Wound Dressings', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Reducing Wound Infections Using Bioelectric Wound Dressings', 'orgStudyIdInfo': {'id': '1840655'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Study participants will undergo surgery using current ERAS protocol standard of care skin cleaning preparation.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'Study participants will use Bioelectrical dressing preoperatively and post-operative.', 'interventionNames': ['Device: Bioelectric dressing']}], 'interventions': [{'name': 'Bioelectric dressing', 'type': 'DEVICE', 'description': 'Participants randomized into the experimental arm will have a bioelectric dressing applied 3 days before surgery, and 3 days post-surgery.', 'armGroupLabels': ['Experimental Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34747', 'city': 'Kissimmee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Petronio Martins, MHA', 'role': 'CONTACT', 'email': 'Petronio.martins@AdventHealth.com', 'phone': '321-299-6655'}, {'name': 'Diana Paredes, BSN', 'role': 'CONTACT', 'email': 'Diana.Paredes@AdventHealth.com', 'phone': '407-535-1984'}], 'facility': 'AdventHealth Celebration', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}], 'centralContacts': [{'name': 'Petronio Martins, MHA', 'role': 'CONTACT', 'email': 'Petronio.martins@adventhealth.com', 'phone': '407-303-5503'}, {'name': 'Diana Paredes, BSN', 'role': 'CONTACT', 'email': 'Diana.Paredes@adventhealth.com', 'phone': '407-303-55-03'}], 'overallOfficials': [{'name': 'Jay Redan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}