Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-01-01
2020-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Floraseal
FloraSeal is a cyanoacrylate-based sealant used in the prevention of surgical site infections.
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.
No interventions assigned to this group
Interventions
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Floraseal
FloraSeal is a cyanoacrylate-based sealant used in the prevention of surgical site infections.
Eligibility Criteria
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Inclusion Criteria
* Have signed the written informed consent form
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Osteoremedies
INDUSTRY
University of Miami
OTHER
Responsible Party
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Victor Hugo Hernandez
Assistant Professor, Arthroplasty & Joint Reconstruction
Principal Investigators
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Victor H Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Hospital
Miami, Florida, United States
Countries
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References
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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. doi: 10.1136/bmj.304.6825.469.
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.
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.
Related Links
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Product information sheet
Other Identifiers
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20180222
Identifier Type: -
Identifier Source: org_study_id
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