Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery

Arthroplasty, Hip Replacement Clinical Trial

Official title:

Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393819
• Other study ID #: RP-002-01072013
• Status: Completed
• Phase: N/A
• Start date: October 29, 2014
• Est. completion date: April 6, 2016

Study information

• Verified date: June 2019
• Source: Lakehead University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 6, 2016
• Est. primary completion date: January 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Hip Replacement
• Infection, Postoperative Wound
• Surgical Wound Infection

Intervention

Drug:
• DuraPrep
DuraPrep surgical solution
• ChloraPrep
ChloraPrep surgical solution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lakehead University	Thunder Bay Regional Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-preparation skin swab	bacterial culture rates following surgical skin preparation	4 minutes post-skin preparation
Secondary	Post-operative skin swab	bacterial culture rates following surgery	immediately after closure of the incision, before drape is removed from operative site
Secondary	Post-operative wound complications	wound complications at follow-up	3 months post-surgery