Floraseal Versus Iodine Impregnated Adhesive Drapes

• ClinicalTrials.gov Identifier: NCT03466489
• Recruitment Status: Withdrawn
• First Posted: March 15, 2018
• Last Update Posted: July 22, 2019
• Sponsor: University of Miami
• Collaborator: Osteoremedies
• Information provided by (Responsible Party): Victor Hugo Hernandez, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Surgical Site Infection; Surgical Wound Infection	Device: Floraseal	Not Applicable

Detailed Description:

Demand for Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA) is increasing steadily and is projected to continue trending upwards in the coming years. Postoperative infections are a common but also potentially devastating complication of total joint arthroplasty.

Various strategies are employed both pre-operatively and post-operatively to prevent this complication. A 2011 Cochrane Review concluded that Iodine impregnated adhesive drapes had no impact on surgical site infection rate when used in various surgical procedures not specific to orthopaedics. The recent SSI prevention guidelines by the World Health Organization did not find any evidence to support the use of adhesive drapes during surgery and recommends against its use.

Currently, iodine impregnated adhesive drapes in conjunction with either chorahexadine gluconate or Iodine Povacrylex and Isopropyl Alcohol are the standard of care at our institution.

FloraSeal is a cyanoacrylate-based sealant. A cyanoacrylate microbial sealant minimizes endogenous bacteria spread to the surgical site by forming a sterile film bonded onto a patient's skin. This film, which is formed upon polymerization, prevents the spread of microorganisms. The protective mechanism is mechanical: the film traps and immobilizes microorganisms that survive on a patient's skin. It has been previously shown to effectively immobilize both gram positive and gram negative bacteria. Additionally, the sealant itself can effectively reduce the superficial bacterial burden on the skin surface and also helps reduce skin moisture buildup on skin.

Furthermore, with conventional adhesive drapes, the edges must be peeled back at the time of skin closure in order to effectively close the surgical site. It is at this moment that the incision becomes most vulnerable to penetration by local microorganisms. FloraSeal and other cyanoacrylate based sealants remain on the skin for 5 to 10 days until the superficial skin sloughs off.

Studies on sterile pig skin demonstrated FloraSeal to be more effective alone at immobilizing bacteria than incisional drapes. The efficacy was the same when FloraSeal was used with or without the incisional drapes, demonstrating that it may be used as a substitute.

Additionally, a 2013 retrospective study in revision shoulder arthroplasty demonstrated a potential reduction in positive intraoperative deep tissue cultures when using a cyanoacrylate-based microbial sealant versus the iodine impregnated incisional drapes. The study lacked sufficient power to reach significance, calling for further investigation of this effect.

Cyanoacrylate has been investigated in other surgical interventions. A 2008 prospective, randomized multicenter clinical trial in patients undergoing elective open hernia repair demonstrated cyanoacrylate-based microbial sealant independently reduced wound contamination over the course of the operation.

Due to the potentially devastating complications associated with postoperative infection, the investigators seek to find alternative methods of prevention of surgical site infection.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prevention of Surgical Site Infections in Total Joint Arthroplasty: Iodine Impregnated Adhesive Drapes Versus Cyanoacrylate-Based Sealant
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: November 1, 2019
• Estimated Study Completion Date: February 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Floraseal; 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; FloraSeal is a cyanoacrylate-based sealant used in the prevention of surgical site infections.
No Intervention: Control; 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.

Outcome Measures

Primary Outcome Measures :

1. Appearance of Surgical Site [ Time Frame: 90 days from date of surgery ]
   The surgical incision will be checked post-operatively for signs of infection or dehiscence.

Secondary Outcome Measures :

1. Intra-operative cultures [ Time Frame: Intra-operative - Cannot be clearly defined as it will depend on the duration of the surgical procedure. ]
   Five wound cultures will be obtained at various points during the operation to test for contamination of the surgical site
2. Post-operative complication - Antibiotic administration [ Time Frame: 90 days from date of surgery ]
   Some surgical site infections may be managed with either intravenous or oral antibiotics. Both groups will be followed to see if either required antibiotic administration.
3. Post-operative complication - Re-operation [ Time Frame: 90 days from date of surgery ]
   Some surgical site infections require surgical debridement. Patients will be followed to determine which patients require re-operation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, Florida

University of Miami Hospital

Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Osteoremedies

Investigators

• Principal Investigator: Victor H Hernandez, MD; University of Miami

More Information

Additional Information:

Product information sheet 

Publications:

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.

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

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.

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.

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. Erratum in: BMJ 1992 Mar 21;304(6829):739.

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

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.

• Responsible Party: Victor Hugo Hernandez, Assistant Professor, Arthroplasty & Joint Reconstruction, University of Miami
• ClinicalTrials.gov Identifier: NCT03466489
• Other Study ID Numbers: 20180222
• First Posted: March 15, 2018
• Last Update Posted: July 22, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The researchers will share aggregate data but no individual's data will be shared. De-identified graphs of the accelerometer or range of motion output recordings from the devices may be used to illustrate the device's application.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Victor Hugo Hernandez, University of Miami:

total joint arthroplasty

Additional relevant MeSH terms:

Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Surgical Wound; Disease Attributes; Pathologic Processes; Postoperative Complications; Wounds and Injuries