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Status:

COMPLETED

Fluid Lavage of Open Wounds

Lead Sponsor:

Prisma Health-Upstate

Collaborating Sponsors:

McMaster University

United States Department of Defense

Conditions:

Open Fracture Wounds

Eligibility:

All Genders

14-85 years

Phase:

NA

Brief Summary

Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these...

Eligibility Criteria

Inclusion

  • Men or women who are skeletally mature.
  • Fracture of any extremity with complete radiographs.
  • Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)\*.
  • Fracture requiring operative fixation.
  • Provision of informed consent.

Exclusion

  • Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC).
  • Known allergy to detergents or castile soap ingredients.
  • Previous wound infection or history of osteomyelitis in the injured extremity.
  • Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation.
  • Surgical delay to operative wound management greater than 24 hours from hospital admission.
  • Use of immunosuppressive medication within 6 months.
  • Immunological deficient disease conditions (e.g. HIV).
  • Fracture of the hand (metacarpals and phalanges).
  • Fracture of the toes (phalanges).
  • Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
  • Previous randomization in this study or a competing study.

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2015

Estimated Enrollment :

2540 Patients enrolled

Trial Details

Trial ID

NCT00788398

Start Date

June 1 2009

End Date

April 1 2015

Last Update

February 11 2016

Active Locations (31)

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Page 1 of 8 (31 locations)

1

Univeristy of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

University of California-Irvine

Orange, California, United States, 92868

3

University of California- San Francisco

San Francisco, California, United States, 94110

4

Wishard Health Services, Indiana University

Indianapolis, Indiana, United States, 46202