Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery

NCT03393819 | Completed

• 1 other identifier: RP-002-01072013
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthroplasty, Hip Replacement; Infection, Postoperative Wound

Keywords

antimicrobial skin solution; skin preparation

Outcome Measures

Primary Outcomes (1)

• Post-preparation skin swab

  bacterial culture rates following surgical skin preparation

  4 minutes post-skin preparation

Secondary Outcomes (2)

• Post-operative skin swab

  immediately after closure of the incision, before drape is removed from operative site

• Post-operative wound complications

  3 months post-surgery

Study Arms (2)

Duraprep Surgical Solution

EXPERIMENTAL

Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions.

Drug: DuraPrep

Chloraprep Surgical Solution

EXPERIMENTAL

Surgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions.

Drug: ChloraPrep

Interventions

DuraPrep DRUG

DuraPrep surgical solution

Also known as: Iodine Povacrylex and Isopropyl Alcohol

Duraprep Surgical Solution

ChloraPrep DRUG

ChloraPrep surgical solution

Also known as: chlorhexidine-alcohol

Chloraprep Surgical Solution

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lakehead University: lead
• Thunder Bay Regional Health Sciences Centre: collaborator

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

DuraPrep; 2-Propanol; Chlorhexidine; Ethanol

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Biguanides; Guanidines; Amidines

Study Officials

• Kurt Droll, MD

  TBRHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon, Assistant Professor

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: October 29, 2014
• Primary Completion: January 7, 2016
• Study Completion: April 6, 2016
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share