NCT01857349

Brief Summary

The goal of this study is to determine the superiority of surgical scrub preparations in total knee arthroplasty based on the bacterial counts present on the skin surface and in the deep joint tissues. These counts will be obtained by culturing the skin prior to any scrub preparation, post preparation after the application of the sterile drapes, deep joint tissue sample prior to wound closure, and immediately post wound closure. This study will provide an assessment of the management of sterility by comparing quantitative and qualitative cultures immediately after surgical scrub preparation and the maintenance of sterility throughout the procedure. This study will enhance prior research efforts by contributing quantitative bacterial load and bacterial load within the surgical wound at closure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

5.2 years

First QC Date

May 15, 2013

Last Update Submit

October 16, 2020

Conditions

Arthroplasty, Replacement

Keywords

Efficacysurgical scrubsTotal Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Quantitative and qualitative bacterial load

    Quantitative and qualitative bacterial load will be obtained by skin cultures and one deep joint tissue culture from the joint space prior to wound closure in primary and revision total knee surgeries.

    At time of surgery

Secondary Outcomes (1)

  • Rate of surgical site infections

    at time of surgery

Study Arms (2)

Chlora Prep

ACTIVE COMPARATOR

Food and Drug Administration (FDA)-approved, surgical skin preparation solution: ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El Paso, Texas)

Other: Chlora Prep

Dura Prep

ACTIVE COMPARATOR

Food and Drug Administration (FDA)-approved, surgical skin preparation solution:DuraPrep (0.7% available iodine and 74% isopropyl alcohol; 3MHealthcare, St. Paul, Minnesota).

Other: Dura Prep

Interventions

Chlora PrepOTHER

Surgical Scrub skin preparation

Also known as: 2% chlorhexidine gluconate and 70% isopropyl alcohol
Chlora Prep
Dura PrepOTHER

Surgical Scrub skin preparation

Also known as: 0.7% available iodine and 74% isopropyl alcohol
Dura Prep

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years old and less than 89
  • Undergoing primary total knee arthroplasty
  • Not undergoing surgical intervention for infection

You may not qualify if:

  • Injury due to trauma
  • Open wound at the incision site determined by pre-op history and physical
  • Abrasion in the vicinity of the planned incision site determined by pre-op history and physical
  • Active infection at or near the surgical incision site determined by pre-op history and physical
  • Active infection somewhere else in the body determined by pre-op labs and history and physical
  • Prior history of surgical infection or bacteremia determined by pre-op history and physical
  • History of rheumatoid arthritis determined by pre-op history and physical
  • History of autoimmune disorder determined by pre-op history and physical
  • Immunosuppressed patient determined by pre-op history and physical
  • Known allergy to iodine, isopropyl alcohol or Chlorhexidine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Science Center Orthopaedic Surgery

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate2-Propanol

Intervention Hierarchy (Ancestors)

PropanolsAlcoholsOrganic Chemicals

Study Officials

  • George W Brindley, MD

    Texas Tech University Health Science Center Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 20, 2013

Study Start

April 1, 2013

Primary Completion

May 30, 2018

Study Completion

July 20, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)