Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery

• ClinicalTrials.gov Identifier: NCT03393819
• Recruitment Status: Completed
• First Posted: January 9, 2018
• Last Update Posted: July 1, 2019
• Sponsor: Lakehead University
• Collaborator: Thunder Bay Regional Health Sciences Centre
• Information provided by (Responsible Party): Kurt Droll, Lakehead University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Arthroplasty, Hip Replacement; Infection, Postoperative Wound	Drug: DuraPrep; Drug: ChloraPrep	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• 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).
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Duraprep Surgical Solution; Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions.	Drug: DuraPrep; 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.	Drug: ChloraPrep; ChloraPrep surgical solution; Other Name: chlorhexidine-alcohol

Outcome Measures

Primary Outcome Measures :

1. Post-preparation skin swab [ Time Frame: 4 minutes post-skin preparation ]
   bacterial culture rates following surgical skin preparation

Secondary Outcome Measures :

1. Post-operative skin swab [ Time Frame: immediately after closure of the incision, before drape is removed from operative site ]
   bacterial culture rates following surgery
2. Post-operative wound complications [ Time Frame: 3 months post-surgery ]
   wound complications at follow-up

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Lakehead University

Thunder Bay Regional Health Sciences Centre

Investigators

• Principal Investigator: Kurt Droll, MD; TBRHSC

More Information

• Responsible Party: Kurt Droll, Orthopaedic surgeon, Assistant Professor, Lakehead University
• ClinicalTrials.gov Identifier: NCT03393819
• Other Study ID Numbers: RP-002-01072013
• First Posted: January 9, 2018
• Last Update Posted: July 1, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kurt Droll, Lakehead University:

antimicrobial skin solution; skin preparation

Additional relevant MeSH terms:

Surgical Wound Infection; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Ethanol; Chlorhexidine; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Disinfectants