Download Report

Management of Open Fractures
Recent Advances and Practices
Andrew N. Pollak, MD
The James Lawrence Kernan Professor and Chairman
Head Division of Orthopaedic Traumatology
Department of Orthopaedics
University of Maryland School of Medicine
Chief of Orthopaedics and Associate Director of Trauma
R Adams Cowley Shock Trauma Center
Chief of Orthopaedics
University of Maryland Medical System
Management of Open Fractures
• What’s new in initial management of open
fractures?
• What role does timing of treatment play in the
management of open fractures?
• What are the relative advantages and
disadvantages of amputation versus limb
salvage in the treatment of high-energy lower
extremity trauma
Initial Management of Open Fractures
• Initial Hemorrhage
Control
• Use of antibiotics
• Techniques of
debridement
– Lavage
• Nailing versus
external fixation
Initial Hemorrhage Control
• Classic Teaching
– Direct pressure
controls most
extremity hemorrhage
– Look for other sources
of hemorrhage if
patient presents with
hypotension
Tourniquet summary
• Early application of tourniquets for treatment
of extremity hemorrhage – before onset of
shock – saves lives
• Complications with liberal use of tourniquets
are rare
• Consider control of extremity bleeding
BEFORE airway management when massive
hemorrhage is evident
Use of Antibiotics in Open Fractures
• Antibiotics for preventing infection in open
limb fractures
– Gosselin, Roberts, Gillespie - Cochrane Database Syst
Rev. 2004;(1):CD003764.
– Data from 913 participants in seven studies
– Antibiotics reduce the incidence of early infections
in open fractures of the limbs. Further placebo
controlled randomised trials are unlikely to be
justified
Antibiotics - Recommendations
• Cultures not helpful in directing therapy
– Pre or post-debridement
• Current recommendations
– First generation cephalosporin for all open
fractures as soon as feasible after diagnosis
– Stop 24 hours after initial debridement
– Repeat peri-operatively after each debridement
for 24 hours
Antibiotics - Recommendations
• High-energy open fractures
– Add gram negative coverage for Type III open
fractures (particularly those with gross
contamination)
• No evidence linking this to decreased infection rate
• May increase resistant strain risk
– Add penicillin or ampicillin for anaerobic coverage
for farm injuries
Techniques of debridement
What are the optimal Irrigation
Techniques and Fluids>
• RCT 458 open fxs/400 pts – castillo soap vs
saline/bacitracin – trend towards reduced
infection risk and wound healing problems with
soap – Anglen JO – JBJS 2005
• Fluid Lavage of Open Wounds (FLOW) pilot – no
significant findings – trends favor low pressure
and soap
• FLOW pivotal trial underway
Adjunctive Treatments
• Local antibiotic delivery, i.e. Bead Pouch
DeCoster TA, Bozorgnia S. Surgical
Techniques: Antibiotic Bead. J Am Acad
Orthop Surg 2008;16:674-678
• Negative Pressure Wound Therapy (NPWT)
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Methods
• A complex musculoskeletal
wound was created on the
hindlimb of 20 goats
• Contaminated with S. aureus
(lux) bacteria
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Methods
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Methods
• Irrigation and Debridement at 6 hours post
contamination
– Imaging done pre and post
• Two different groups
– Control group: Antibiotic bead pouch (ABP)
– Experimental group: NPWT + antibiotic PMMA beads
(augmented NPWT)
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Methods
• Vancomycin
– (2g/40g bag cement)
• 16 beads per goat
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Methods
• Antibiotic levels measured
in effluent
– 6, 12, 24, 36, 42 hours post
treatment
• Final imaging performed at
48 hours
Results
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Results
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Results
6 hours
6 hours
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Results
48 hours
48 hours
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Results
6 hours
48 hours
6 hours
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
48 hours
Results
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Perspective
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Perspective
Ladder of Bacteria
Reduction
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Perspective
Ladder of Bacteria
Reduction
ABP
aNPWT
NPWT +Silver
(Unpublished data)
NPWT
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Courtesy Josh Wenke, PhD &CPT Dan Stinner, MD
Ladder of Bacteria
Reduction
Antibiotic Sponge w/ NPWT
Antibiotic Sponge Pouch
Antibiotic Bead Pouch
Augmented NPWT
(Abx Beads w/ NPWT)
NPWT w/ Silver Dressing
Standard NPWT
Wet-to-Dry Dressings
400%
300%
200%
Percent of Baseline
100%
0%
Closure/Coverage of Open Fractures
• Soft tissue coverage
as soon as
technically possible
for IIIA injuries
– Return for repeat
debridement if
deemed appropriate
Closure/Coverage of Open Fractures
• Flap Coverage within
7 days of injury if
possible for IIIB
injuries
– May be determined
by patient factors
Immediate nailing of open tibia fractures
SPRINT Study – JBJS 2008
35/400 = 9% infection rate
Military rates higher – 14.9% Lacap & Frisch, 40% Mody, et al. J Trauma 2009
Majority of civilian open fractures in 2013 can be safely
managed with protocol of early antibiotics,
debridement, internal fixation including reamed nailing
Indications for definitive external fixation
• Severe contamination
where thorough
debridement not certain
• Complex fracture pattern
where transport may be
desirable
• Host factors
– Diabetes
– Hepatic insufficiency
Timing of Debridement
basic science argument
• Substance of the argument
– Friedrich studies
– Bacterial debridement easier prior to 2 hours
• Less adherence, less biofilm formation
– More difficult after 6 hours
– Devitalized bone likely presents an idealized binding
surface
– In vitro studies have demonstrated time-dependent
efficacy of bacterial removal procedures (debridement)
– Applies primarily to availability of idealized binding
surfaces
Timing of Debridement
clinical argument
• Schenker, et al. – systematic review of the
literature
– 16 studies – 3539 open fractures met inclusion
criteria
– No significant difference between open fractures
treated early or late regardless of time threshold
used, open fracture severity or depth of infection
– No clinical support in literature for “6 hour rule”
Limb Salvage versus Amputation
• Make sure all questions are covered
The LEAP Study
• Prospective, Longitudinal, Observational, Outcomes
Study
• 8 - Level 1 American Trauma Centers
– Accepted Principles of Fracture Care Protocol
– Attending surgeons direct all evaluations, decisions and
extremity treatment
• 656 eligible patients , ages 16 -69
– 55 exclusions
• 36 – refusal to participate
• 13 – in-hospital death
• 6 – administrative failure to enroll
• 601 Patients
LEAP Function at 2 Years
Total
N=464
Amps
N=133
ALL Recons
N=331
IIIB
N=136
FA/Pilon
N=94
% FWB
92.8
91.1
93.4
92.3
93
% RTW
51
53
49.4
48.4
55.7
Mean VAS
27
25
27.8
28.4
30.1
Mean SIP
12
12.6
11.8
13.2
11.8
% SIP ≥ 10
42.2
43.9
41.5
47.4
40.4
Sensation at 24 months for pts with
initial impaired sensation
Normal
%
Impaired
Absent
Amputated
100
80
60
40
20
0
Group III Salvage
Controls
LEAP Summary
• Limb salvage scoring systems are not valuable
in determining need to amputate or potential
to salvage
• Outcomes are equally poor for limb salvage
and amputation long-term
– METALS did NOT disprove this
LEAP Summary
• Amputation costs MORE than limb salvage
long-term
– Primarily because of prosthetic costs
• Absence of plantar sensation on initial
examination predicts NOTHING!!!
LEAP Summary
• Approximately 50% of LEAP patients who were
gainfully employed prior to their injury had
returned to work at 2 years post-injury
• Absence of plantar sensation on initial
examination predicts NOTHING!!!
• Infection predicts poorer clinical outcome
The Major Extremity Trauma
Research Consortium
METRC
Extremity War Injuries - Background
• Casualty volume from Operation Iraqi Freedom
(OIF)/Operation Enduring Freedom (OEF) has been
the highest since Vietnam.
• Approaching 50,000 military personnel have
sustained combat related injuries.
• Military surgeons have had to provide care to multinational force members, civilian contractors, Iraqi
civilians and suspected insurgents, in addition to our
own personnel.
Orthopaedic Military – Civilian Patient
Care
• What the military surgeons learn during wartime, the civilian
surgeons try to perfect during peacetime
• Overtime, civilian trauma patients receive the greatest
benefit from our wartime advances
–
–
–
–
–
–
–
Resuscitation
Hand surgery
Vascular Surgery
Trauma Center Concepts
Wound Care
Amputations
Rehabilitation
Orthopaedic Research Funding in Defense Appropriations
Bills (millions)
(President’s request each year = “0”)
Congressional Appropriations
140
120
Congressional
Appropriations
100
80
60
40
20
0
FY 06 FY 07 FY 08 FY 09 FY 10 FY 11 FY 12 FY 13
Consortium Approach
• Develop a Research Agenda
• Establish a centralized Data
Coordinating Center
• Take advantage of experts in
the design and running clinical
trials
• Pay attention to efficiency
• Collect data uniformly across
studies
• Leverage resources
METRC ORGANIZATIONAL CHART
Potential Partners
Gov’t Steering Committee
NIH
Industry
DSMB
Executive Committee
Liaisons
METRC Steering Committee
AFIRM
VA
Coordinating
Center
Satellite Centers
CORE
CORE
CORE
CORE
Other
Committees
CORE
CORE
CORE
CORE
CORE
CORE
CORE
CORE
CORE
CORE
CORE
CORE
CORE
Publications
Committee
CORE
Protocol
Protocol
Committee
Protocol
Committee
Protocol
Committee
Protocol
Committee
Committee
Adjudication
Committee
CORE
CORE
CORE
CORE
CORE
CORE
Data
Standards
Committee
METRC CLINICAL SITES
• 26 Core Sites
– 22 Civilian Centers
– 4 Military Centers
•
•
•
•
WRNMMC
SAMMC
NMCP
NMCSD
• 30 Satellite Centers
REGISTRY DATA
The power of numbers . . .
Annual Number at the 24
Core Civilian Centers
LEF / Type III
UEF / Type III
Pelvic Fxs
Complex Foot
Amputations
5,628 / 775
1,330 / 170
1,900
956
294
METRC Studies: Infection
RCTs to Compare Existing Txs and Evaluate
Promising New Approaches
FIXIT Trial: Comparing Nails vs. Ring Fixation for Type
III B Tibias
POvIV Trial: IV or PO antibiotic therapies for the
treatment of deep infections
APS Trial: Investigating the use of an Antibacterial
Plate Sleeve (APS) in reducing the rate of surgical site
infections after operative treatment of high-energy fxs
Oxygen Trial: Effects of high dose perioperative oxygen
on the rate of surgical site infection
METRC Studies: Infection
Developing a Better Understanding of
Wound Flora
BIOBURDEN STUDY: A prospective
observational study to characterize modern
wound bioburden at time of closure and
correlate with incidence of downstream
infections - we will also compare PCR (Ibis
5000) vs. standard culture
Results will drive development of RCTs
employing local/topical anti-microbial
wound therapy
Status of METRC Studies
 6 Studies are enrolling patients
 3 Studies recently implemented
 4 studies in regulatory review
A total of 723 patients have been enrolled
METRC Leader Board
#1
#2
#3
#4
#5
#6
#7
#8
#9
#10
CMC
UMD
HOU
VMC
UMS
WFU
RYD
MET
MIN
ORL
Total
ALL Sites
131
100
91
55
34
33
29
26
25
25
723
Studies Underway at
Shock Trauma:
• FIXIT
• BIOBURDEN
• OUTLET
• TCCS
• PAIN
•PACS
ON-GOING CHALLENGES
• Efficiency of running large trials & working
through regulatory process
• Methodological Challenges (many):
– Strong surgeon preferences
– Patient recruitment and follow-up
• Cannot support further studies that will compete
for patients needed in ongoing studies . . . e.g.
severe tibia fractures
• Satellite centers are critical to our success !