Reducing Wound Infections Using Bioelectric Wound Dressings

Overview

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.

Detailed description

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.

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.

Interventions

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

Primary outcome measures

• Quantitative bacterial count [Time frame: 4 total biopsies will be collected. (3 days before surgery, surgery day pre incision, immediately post-surgery and 3 days post-surgery)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• AdventHealth Celebration — Kissimmee

Publications

• 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 Recommen PMID 30426190
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06312267 · 1840655

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗