Floraseal Versus Iodine Impregnated Adhesive Drapes

Not Applicable

Withdrawn

• Conditions: Surgical Site Infection; Surgical Wound Infection
• Interventions: Device: Floraseal

• Registration Number: NCT03466489
• Lead Sponsor: University of Miami

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-22
• Primary Completion: 2019-11-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Floraseal	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.

Primary Outcome Measures

Name	Time	Method
Appearance of Surgical Site	90 days from date of surgery	The surgical incision will be checked post-operatively for signs of infection or dehiscence.

Secondary Outcome Measures

Name	Time	Method
Post-operative complication - Antibiotic administration	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.
Post-operative complication - Re-operation	90 days from date of surgery	Some surgical site infections require surgical debridement. Patients will be followed to determine which patients require re-operation.
Intra-operative cultures	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

Trial Locations

Locations (1)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States