NCT01069315

Brief Summary

The purpose of this trial is to investigate whether irrigation solution (soap vs. saline solution), or irrigation pressure (high vs. low) will decrease the rate of infection among patients with open fracture wounds.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
3 countries

9 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

March 18, 2019

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

February 16, 2010

Results QC Date

September 14, 2017

Last Update Submit

March 15, 2019

Conditions

InfectionWound Healing ProblemNonunion

Keywords

open woundsolutionpressurerandomized

Outcome Measures

Primary Outcomes (1)

  • The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).

    one year

Secondary Outcomes (5)

  • The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.

    1 year

  • Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Solution).

    1 year

  • Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Solution).

    one year

  • Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Pressure)

    one year

  • Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Pressure)

    one year

Study Arms (4)

Normal saline and High pressure

EXPERIMENTAL

Irrigation with normal saline delivered at high pressure

Procedure: Type of fluid lavage solutionProcedure: Type of fluid lavage pressure

Soap solution and High pressure

EXPERIMENTAL

Irrigation with soap solution delivered at high pressure

Procedure: Type of fluid lavage solutionProcedure: Type of fluid lavage pressure

Normal saline and Low pressure

EXPERIMENTAL

Irrigation with saline solution delivered at low pressure

Procedure: Type of fluid lavage solutionProcedure: Type of fluid lavage pressure

Soap solution and Low pressure

EXPERIMENTAL

Irrigation with soap solution delivered at low pressure

Procedure: Type of fluid lavage solutionProcedure: Type of fluid lavage pressure

Interventions

Type of fluid lavage solutionPROCEDURE

Comparison of castile soap solution vs. normal saline solution.

Normal saline and High pressureNormal saline and Low pressureSoap solution and High pressureSoap solution and Low pressure
Type of fluid lavage pressurePROCEDURE

Comparison of low pressure vs. high pressure.

Normal saline and High pressureNormal saline and Low pressureSoap solution and High pressureSoap solution and Low pressure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • skeletally mature
  • sustained an open fracture of the appendicular skeleton (type I to IIIb).

You may not qualify if:

  • vascular deficit
  • \[any\] allergy to detergents or castile soap
  • previous wound infection or osteomyelitis
  • previous fracture with retained hardware in the injured extremity
  • operative management more than 24 hours after injury
  • use of immunosuppressive medication within six months
  • immunological deficiency or disease conditions
  • fractures of the hands (distal to the carpus) or toes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Missouri Health Care

Columbia, Missouri, United States

Location

Greenville Hospital System

Greenville, South Carolina, United States

Location

East Texas Medical Centre

Tyler, Texas, United States

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2A7, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 8E7, Canada

Location

Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Sancheti Institute for Orthopaedics & Rehabilitation

Pune, Maharashtra, India

Location

Related Publications (29)

  • Dormans JP, Fisher RC, Pill SG. Orthopaedics in the developing world: present and future concerns. J Am Acad Orthop Surg. 2001 Sep-Oct;9(5):289-96. doi: 10.5435/00124635-200109000-00002.

    PMID: 11575908BACKGROUND

  • Charles Court-Brown, Margaret McQueen, Paul Tornetta III. Trauma. 1st ed. Philadelphia: Lippincott Williams and Wilkins, 2006.

    BACKGROUND

  • Anglen JO. Wound irrigation in musculoskeletal injury. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):219-26. doi: 10.5435/00124635-200107000-00001.

    PMID: 11476531BACKGROUND

  • Khatod M, Botte MJ, Hoyt DB, Meyer RS, Smith JM, Akeson WH. Outcomes in open tibia fractures: relationship between delay in treatment and infection. J Trauma. 2003 Nov;55(5):949-54. doi: 10.1097/01.TA.0000092685.80435.63.

    PMID: 14608171BACKGROUND

  • Bhandari M, Guyatt GH, Swiontkowski MF, Schemitsch EH. Treatment of open fractures of the shaft of the tibia. J Bone Joint Surg Br. 2001 Jan;83(1):62-8. doi: 10.1302/0301-620x.83b1.10986.

    PMID: 11245540BACKGROUND

  • Bhandari M, Tornetta P 3rd, Sprague S, Najibi S, Petrisor B, Griffith L, Guyatt GH. Predictors of reoperation following operative management of fractures of the tibial shaft. J Orthop Trauma. 2003 May;17(5):353-61. doi: 10.1097/00005131-200305000-00006.

    PMID: 12759640BACKGROUND

  • Spencer J, Smith A, Woods D. The effect of time delay on infection in open long-bone fractures: a 5-year prospective audit from a district general hospital. Ann R Coll Surg Engl. 2004 Mar;86(2):108-12. doi: 10.1308/003588404322827491.

    PMID: 15005929BACKGROUND

  • Anglen JO. Comparison of soap and antibiotic solutions for irrigation of lower-limb open fracture wounds. A prospective, randomized study. J Bone Joint Surg Am. 2005 Jul;87(7):1415-22. doi: 10.2106/JBJS.D.02615.

    PMID: 15995106BACKGROUND

  • Burd T, Christensen GD, Anglen JO, Gainor BJ, Conroy BP, Simpson WA. Sequential irrigation with common detergents: a promising new method for decontaminating orthopedic wounds. Am J Orthop (Belle Mead NJ). 1999 Mar;28(3):156-60.

    PMID: 10195838BACKGROUND

  • Petrisor B, Jeray K, Schemitsch E, Hanson B, Sprague S, Sanders D, Bhandari M; FLOW Investigators. Fluid lavage in patients with open fracture wounds (FLOW): an international survey of 984 surgeons. BMC Musculoskelet Disord. 2008 Jan 23;9:7. doi: 10.1186/1471-2474-9-7.

    PMID: 18215287BACKGROUND

  • Anglen J, Apostoles PS, Christensen G, Gainor B, Lane J. Removal of surface bacteria by irrigation. J Orthop Res. 1996 Mar;14(2):251-4. doi: 10.1002/jor.1100140213.

    PMID: 8648503BACKGROUND

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PMID: 8628042BACKGROUND

  • Brooks R, Rabin RE, de Charro F. The measurement and valuation of health status using EQ-5D: a European perspective. Kluwer Academic Publishers, 2003.

    BACKGROUND

  • Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

    PMID: 11491192BACKGROUND

  • Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available.

    PMID: 1334988BACKGROUND

  • Owens BD, White DW, Wenke JC. Comparison of irrigation solutions and devices in a contaminated musculoskeletal wound survival model. J Bone Joint Surg Am. 2009 Jan;91(1):92-8. doi: 10.2106/JBJS.G.01566.

    PMID: 19122083BACKGROUND

  • Bhandari M, Adili A, Schemitsch EH. The efficacy of low-pressure lavage with different irrigating solutions to remove adherent bacteria from bone. J Bone Joint Surg Am. 2001 Mar;83(3):412-9. doi: 10.2106/00004623-200103000-00014.

    PMID: 11263646BACKGROUND

  • Anglen JO, Gainor BJ, Simpson WA, Christensen G. The use of detergent irrigation for musculoskeletal wounds. Int Orthop. 2003;27(1):40-6. doi: 10.1007/s00264-002-0398-5. Epub 2002 Nov 9.

    PMID: 12582808BACKGROUND

  • Anglen JO, Apostoles S, Christensen G, Gainor B. The efficacy of various irrigation solutions in removing slime-producing Staphylococcus. J Orthop Trauma. 1994 Oct;8(5):390-6. doi: 10.1097/00005131-199410000-00004.

    PMID: 7996321BACKGROUND

  • Malten KE, den Arend JA. Irritant contact dermatitis. Traumiterative and cumulative impairment by cosmetics, climate, and other daily loads. Derm Beruf Umwelt. 1985;33(4):125-32.

    PMID: 4042875BACKGROUND

  • Strube DD, Nicoll G. The irritancy of soaps and syndets. Cutis. 1987 Jun;39(6):544-5.

    PMID: 3608584BACKGROUND

  • Simion FA, Rhein LD, Morrison BM Jr, Scala DD, Salko DM, Kligman AM, Grove GL. Self-perceived sensory responses to soap and synthetic detergent bars correlate with clinical signs of irritation. J Am Acad Dermatol. 1995 Feb;32(2 Pt 1):205-11. doi: 10.1016/0190-9622(95)90127-2.

    PMID: 7829704BACKGROUND

  • Bhandari M, Adili A, Lachowski RJ. High pressure pulsatile lavage of contaminated human tibiae: an in vitro study. J Orthop Trauma. 1998 Sep-Oct;12(7):479-84. doi: 10.1097/00005131-199809000-00009.

    PMID: 9781772BACKGROUND

  • Bhandari M, Schemitsch EH, Adili A, Lachowski RJ, Shaughnessy SG. High and low pressure pulsatile lavage of contaminated tibial fractures: an in vitro study of bacterial adherence and bone damage. J Orthop Trauma. 1999 Nov;13(8):526-33. doi: 10.1097/00005131-199911000-00002.

    PMID: 10714777BACKGROUND

  • Dirschl DR, Duff GP, Dahners LE, Edin M, Rahn BA, Miclau T. High pressure pulsatile lavage irrigation of intraarticular fractures: effects on fracture healing. J Orthop Trauma. 1998 Sep-Oct;12(7):460-3. doi: 10.1097/00005131-199809000-00005.

    PMID: 9781768BACKGROUND

  • Bhandari M, Schemitsch EH. High-pressure irrigation increases adipocyte-like cells at the expense of osteoblasts in vitro. J Bone Joint Surg Br. 2002 Sep;84(7):1054-61. doi: 10.1302/0301-620x.84b7.12532.

    PMID: 12358372BACKGROUND

  • Adili A, Bhandari M, Schemitsch EH. The biomechanical effect of high-pressure irrigation on diaphyseal fracture healing in vivo. J Orthop Trauma. 2002 Jul;16(6):413-7. doi: 10.1097/00005131-200207000-00008.

    PMID: 12142830BACKGROUND

  • Sprague S, Tornetta P 3rd, Slobogean GP, O'Hara NN, McKay P, Petrisor B, Jeray KJ, Schemitsch EH, Sanders D, Bhandari M; FLOW Investigators. Are large clinical trials in orthopaedic trauma justified? BMC Musculoskelet Disord. 2018 Apr 20;19(1):124. doi: 10.1186/s12891-018-2029-3.

    PMID: 29678204DERIVED

  • FLOW Investigators; Petrisor B, Sun X, Bhandari M, Guyatt G, Jeray KJ, Sprague S, Tanner S, Schemitsch E, Sancheti P, Anglen J, Tornetta P, Bosse M, Liew S, Walter S. Fluid lavage of open wounds (FLOW): a multicenter, blinded, factorial pilot trial comparing alternative irrigating solutions and pressures in patients with open fractures. J Trauma. 2011 Sep;71(3):596-606. doi: 10.1097/TA.0b013e3181f6f2e8.

    PMID: 21378581DERIVED

MeSH Terms

Conditions

Infections

Results Point of Contact

Title
Paula McKay, Manager
Organization
McMaster University
mckayp@mcmaster.ca
9055274322

Study Officials

  • Mohit Bhandari, MD, FRCSC

    McMaster University

    STUDY CHAIR

  • Mohit Bhandari, MD, FRCSC

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Gordon Guyatt, MD, FRCSC

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Kyle J Jeray, MD, FRCSC

    McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

July 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 18, 2019

Results First Posted

March 18, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)CA(5)IN(1)