Floraseal Versus Iodine Impregnated Adhesive Drapes

NCT03466489 | Withdrawn DMC FDA Device

• 1 other identifier: 20180222
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Infection after total joint arthroplasty can have devastating consequences. Adhesive drapes have been traditionally used at our institution to help reduce the risk of wound contamination and infection by superficial skin flora. Our primary objective is to determine if a cyanoacrylate-based sealant (FloraSeal microbial sealant) is superior to conventional iodine impregnated drapes in prevention of both superficial and deep surgical site infections in total joint arthroplasty (TJA) patients. A prospective, randomized controlled model will be used to answer this question.

Conditions

Surgical Site Infection; Surgical Wound Infection

Keywords

total joint arthroplasty

Outcome Measures

Primary Outcomes (1)

• Appearance of Surgical Site

  The surgical incision will be checked post-operatively for signs of infection or dehiscence.

  90 days from date of surgery

Secondary Outcomes (3)

• Intra-operative cultures

  Intra-operative - Cannot be clearly defined as it will depend on the duration of the surgical procedure.

• Post-operative complication - Antibiotic administration

  90 days from date of surgery

• Post-operative complication - Re-operation

  90 days from date of surgery

Study Arms (2)

Floraseal

EXPERIMENTAL

The surgical site will first be cleaned with isopropyl alcohol. Once the site is dry, alcohol based chlorhexidine gluconate preparatory solution will be applied to the surgical site. Once dry, the FloraSeal surgical preparatory solution will be applied per the manufacturers recommendations. The extremity will be draped in sterile fashion however adhesive drapes over the surgical site itself will not be applied.

Device: Floraseal

Control

NO INTERVENTION

The operative site is first cleaned with isopropyl alcohol. Once the site is dry, alcohol based chlorhexidine gluconate preparatory solution will be applied to the surgical site. The operative site will then be draped in sterile fashion. An iodine impregnated adhesive drape will then be applied to the surgical site.

Interventions

Floraseal DEVICE

FloraSeal is a cyanoacrylate-based sealant used in the prevention of surgical site infections.

Floraseal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age
• Have signed the written informed consent form

You may not qualify if:

• Patients not fluent in the language of the informed consent form
• Prisoners
• Pregnancy
• Reported to have mental illness or belonging to a vulnerable population
• History of dermatitis or allergic reaction to cyanoacrylate based materials or iodine
• Patients undergoing revision total joint arthroplasty secondary to infection
• Allergy to Iodine.
• Patients undergoing total joint arthroplasty in the setting of acute trauma

Sponsors & Collaborators

• University of Miami: lead
• Osteoremedies: collaborator

Study Sites (1)

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Related Publications (7)

• Prince D, Kohan K, Solanki Z, Mastej J, Prince D, Varughese R, et al. Immobilization and death of bacteria by Flora Seal® microbial sealant. International Journal of Pharmaceutical Science Invention. 2017 Jun;6(6):45-9.

  BACKGROUND

• Zhang S, Ruiz R. FloraSeal® microbial sealant: a comprehensive solution to skin flora. 2015.

  BACKGROUND

• Lorenzetti AJ, Wongworawat MD, Jobe CM, Phipatanakul WP. Cyanoacrylate microbial sealant may reduce the prevalence of positive cultures in revision shoulder arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3225-9. doi: 10.1007/s11999-013-2854-5.

  PMID: 23471553 BACKGROUND

• Towfigh S, Cheadle WG, Lowry SF, Malangoni MA, Wilson SE. Significant reduction in incidence of wound contamination by skin flora through use of microbial sealant. Arch Surg. 2008 Sep;143(9):885-91; discussion 891. doi: 10.1001/archsurg.143.9.885.

  PMID: 18794427 BACKGROUND

• Bailey IS, Karran SE, Toyn K, Brough P, Ranaboldo C, Karran SJ. Community surveillance of complications after hernia surgery. BMJ. 1992 Feb 22;304(6825):469-71. doi: 10.1136/bmj.304.6825.469.

  PMID: 1547415 BACKGROUND

• Webster J, Alghamdi A. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database Syst Rev. 2015 Apr 22;2015(4):CD006353. doi: 10.1002/14651858.CD006353.pub4.

  PMID: 25901509 BACKGROUND

• Fairclough JA, Johnson D, Mackie I. The prevention of wound contamination by skin organisms by the pre-operative application of an iodophor impregnated plastic adhesive drape. J Int Med Res. 1986;14(2):105-9. doi: 10.1177/030006058601400210.

  PMID: 3699240 BACKGROUND

Related Links

• Product information sheet

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Officials

• Victor H Hernandez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Arthroplasty & Joint Reconstruction

Model Details: Randomized

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 15, 2018
• Study Start: January 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: February 1, 2020
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)