Arthroplasty, Hip Replacement, Infection, Postoperative Wound
Conditions
Keywords
antimicrobial skin solution, skin preparation
Brief summary
This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol) at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.
Detailed description
Post-operative infections, although rare, can lead to significant patient morbidity and cost. A potential risk factor for the development of post-operative wound infection is the amount of bacterial skin flora present at the operative site at the time of surgery. Therefore, the use of an effective anti-microbial preoperative skin-preparation solution is essential in preventing the contamination of the surgical site and in turn the surgical wound. Several different types of anti-microbial skin preparation solutions are presently used pre-operatively. However, there is currently no consensus on which solution is superior. Previous studies have investigated the efficacy of commonly used solutions in the shoulder, foot and spine, however the bacterial flora from these areas are likely different from the hip region. Thus the findings in the literature are not necessarily applicable to surgery involving the hip. Because of the potentially devastating consequences of a surgical wound infection, ensuring effective skin preparation prior to surgery is critical. Therefore the identification of a superior skin-preparation solution for the elimination of bacterial pathogens, specific to the hip region, could potentially have considerable impact on the clinical care of patients undergoing hip arthroplasty surgery. This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol), at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.The primary outcome is as follows: positive culture rates of residual bacteria following surgical skin preparation. Secondary outcomes that will be evaluated is culture rates post-surgery (following skin closure) and acute (within 3 months) post-operative wound complications.
Interventions
DRUGDuraPrep
DuraPrep surgical solution
DRUGChloraPrep
ChloraPrep surgical solution
Sponsors
Thunder Bay Regional Health Sciences Centre
Lakehead University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding of the participants and care providers after the assignment of the intervention is not possible as the two solutions are distinct, and one creates a unique discolouration of the skin. Those performing the laboratory analysis and reporting the results of the bacterial culture of will be blind to which treatment the participant was assigned (i.e. the label will not identify which group the participant belongs to).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Has consented for primary total hip arthroplasty by any of the following orthopaedic surgeons: Drs. Kurt Droll, Dave Puskas or Claude Cullinan * Are capable of providing their own consent * Are able to adequately communicate in English to undergo informed consent * Has provided written, informed consent for the study
Exclusion criteria
* Previous hip arthroplasty * Evidence of an open wound at the incision site * Evidence of an abrasion in the vicinity of the planned incision * Evidence of an active infection at or near the surgical site * Evidence of an active infection elsewhere in the body * Are chronically immunosuppressed e.g. transplant * Is deemed not suitable for the study in the opinion of an investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-preparation skin swab | 4 minutes post-skin preparation | bacterial culture rates following surgical skin preparation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative skin swab | immediately after closure of the incision, before drape is removed from operative site | bacterial culture rates following surgery |
| Post-operative wound complications | 3 months post-surgery | wound complications at follow-up |
Outcome results
None listed