Reducing Wound Infections Using Bioelectric Wound Dressings

NCT06312267 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 1840655
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Surgical Site Infection

Keywords

Surgery outcomes; Bioelectric dressing,

Outcome Measures

Primary Outcomes (1)

• Quantitative bacterial count

  Skin biopsies will be collected and analyzed for bacterial counts

  4 total biopsies will be collected. (3 days before surgery, surgery day pre incision, immediately post-surgery and 3 days post-surgery)

Study Arms (2)

Control Arm

NO INTERVENTION

Study participants will undergo surgery using current ERAS protocol standard of care skin cleaning preparation.

Experimental Arm

EXPERIMENTAL

Study participants will use Bioelectrical dressing preoperatively and post-operative.

Device: Bioelectric dressing

Interventions

Bioelectric dressing DEVICE

Participants randomized into the experimental arm will have a bioelectric dressing applied 3 days before surgery, and 3 days post-surgery.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective diverticular, benign polyp, or colon cancer resection
• Age 18-90 years old
• All patients must receive some kind of bowel prep (SU- prep, pills, Go-Lytely, milk of magnesia, etc.…)
• Must be off antibiotics for more than 2 weeks before surgery
• Surgery must be laparoscopic, hand assisted or Robotic
• Skin will be closed in layers and subcuticular interrupted fashion
• Just one dose of preoperative antibiotics (Invanz or equivalent if patient is allergic)
• Patients will have a primary anastomosis, no colostomy.
• Patient must be compliant with dressing care
• Ability to provide informed consent

You may not qualify if:

• Active infections before surgery -example: Intra-abdominal abscess not drained or actively on antibiotics on the day of surgery, skin infections
• Inability to take intestinal bowel preparation
• HgbA1c \>8
• BMI \>40
• Immunosuppression
• Need of steroid stress dose pre-op
• Patient receiving active chemotherapy
• Need of stoma (end ostomies after resection protective stoma included)
• Need of blood transfusion during surgery
• Use of irrigation with antibiotics or IRRISEPTR during surgery
• Any standard contraindication to anesthesia and/or surgery
• Pregnancy or lactating women
• Inability to provide informed consent
• Inability to follow instructions for dressing care
• Sensitivity or allergy to silver or zinc

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Celebration

Kissimmee, Florida, 34747, United States

Location

Related Publications (10)

• 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: 30426190 BACKGROUND

• 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: 30195951 BACKGROUND

• 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: 27168571 BACKGROUND

• 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: 25803639 BACKGROUND

• 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: 24595050 BACKGROUND

• 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: 29099398 BACKGROUND

• 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: 24627730 BACKGROUND

• 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: 25647504 BACKGROUND

• 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: 32648141 BACKGROUND

• 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.

  PMID: 21768407 RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay Redan, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: March 4, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)