Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery
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|ClinicalTrials.gov Identifier: NCT03393819|
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : July 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Hip Replacement Infection, Postoperative Wound||Drug: DuraPrep Drug: ChloraPrep||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|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).|
|Official Title:||Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery|
|Actual Study Start Date :||October 29, 2014|
|Actual Primary Completion Date :||January 7, 2016|
|Actual Study Completion Date :||April 6, 2016|
Experimental: Duraprep Surgical Solution
Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions.
DuraPrep surgical solution
Other Name: Iodine Povacrylex and Isopropyl Alcohol
Experimental: Chloraprep Surgical Solution
Surgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions.
ChloraPrep surgical solution
Other Name: chlorhexidine-alcohol
- Post-preparation skin swab [ Time Frame: 4 minutes post-skin preparation ]bacterial culture rates following surgical skin preparation
- Post-operative skin swab [ Time Frame: immediately after closure of the incision, before drape is removed from operative site ]bacterial culture rates following surgery
- Post-operative wound complications [ Time Frame: 3 months post-surgery ]wound complications at follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393819
|Principal Investigator:||Kurt Droll, MD||TBRHSC|