Prevention of Surgical Site Infections in Total Joint Arthroplasty: Iodine Impregnated Adhesive Drapes Versus Cyanoacrylate-Based Sealant
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Miami
- Locations
- 2
- Primary Endpoint
- Appearance of Surgical Site
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Floraseal (Device)
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.
Outcomes
Primary Outcomes
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 Outcomes
- Post-operative complication - Antibiotic administration(90 days from date of surgery)
- Post-operative complication - Re-operation(90 days from date of surgery)
- Intra-operative cultures(Intra-operative - Cannot be clearly defined as it will depend on the duration of the surgical procedure.)
Investigators
Victor Hugo Hernandez
Assistant Professor, Arthroplasty & Joint Reconstruction
University of Miami