Reducing Wound Infections Using Bioelectric Wound Dressings
NCT ID: NCT06312267
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-03-04
2025-03-01
Brief Summary
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Detailed Description
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Under 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.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control Arm
Study participants will undergo surgery using current ERAS protocol standard of care skin cleaning preparation.
No interventions assigned to this group
Experimental Arm
Study participants will use Bioelectrical dressing preoperatively and post-operative.
Bioelectric dressing
Participants randomized into the experimental arm will have a bioelectric dressing applied 3 days before surgery, and 3 days post-surgery.
Interventions
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Bioelectric dressing
Participants randomized into the experimental arm will have a bioelectric dressing applied 3 days before surgery, and 3 days post-surgery.
Eligibility Criteria
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Inclusion Criteria
2. Age 18-90 years old
3. All patients must receive some kind of bowel prep (SU- prep, pills, Go-Lytely, milk of magnesia, etc.…)
4. Must be off antibiotics for more than 2 weeks before surgery
5. Surgery must be laparoscopic, hand assisted or Robotic
6. Skin will be closed in layers and subcuticular interrupted fashion
7. Just one dose of preoperative antibiotics (Invanz or equivalent if patient is allergic)
8. Patients will have a primary anastomosis, no colostomy.
9. Patient must be compliant with dressing care
10. Ability to provide informed consent
Exclusion Criteria
2. Inability to take intestinal bowel preparation
3. HgbA1c \>8
4. BMI \>40
5. Immunosuppression
6. Need of steroid stress dose pre-op
7. Patient receiving active chemotherapy
8. Need of stoma (end ostomies after resection protective stoma included)
9. Need of blood transfusion during surgery
10. Use of irrigation with antibiotics or IRRISEPTR during surgery
11. Any standard contraindication to anesthesia and/or surgery
12. Pregnancy or lactating women
13. Inability to provide informed consent
14. Inability to follow instructions for dressing care
15. Sensitivity or allergy to silver or zinc
18 Years
90 Years
ALL
No
Sponsors
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AdventHealth
OTHER
Responsible Party
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Principal Investigators
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Jay Redan, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth
Locations
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AdventHealth Celebration
Kissimmee, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1840655
Identifier Type: -
Identifier Source: org_study_id
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