Fractures, OpenPROOFNCT00870064
The Treatment of Type I Open Fractures in Pediatrics
A study testing Formal Operative Treatment and Emergency Department Treatment in people with Fractures, Open, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Fractures, Open
- What is being tested?
- Formal Operative Treatment and Emergency Department Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- open fracture amenable to treatment by closed reduction
- low energy mechanism of injury (e.g., falls from less than 10 feet, bicycle accidents)
- wound less than 1cm in length and the bone not visualized through the skin
Who cannot join
- open fracture not amenable to treatment by closed reduction
- open fracture that would typically require operative reduction and fixation
- high energy mechanism of injury (e.g., struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet)
- wound greater than 1cm in length
- gross contamination of wound
- open fractures involving hands or feet (the current standard of care to treat open injuries involving hands or feet is only emergency room management)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Joseph (Jay) A Janicki, MD, MS, 312-227-6194, jjanicki@luriechildrens.org
Carly A Strohbach, BA, 312-227-6627, cstrohbach@luriechildrens.org
About this study
Official title: The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement
Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor open fractures can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. Children who meet the study criteria will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Outcomes from each group will be evaluated and compared, including rate of infection, number of return visits to the operating room, time to union, and other complications.
Read the detailed description
Fractures in which bone has been exposed to the outside world through an associated skin injury, known as open fractures, are frequently encountered in orthopaedics. Traditionally, treatment calls for a formal, operative treatment in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. The bone itself, depending on the age of the patient, fracture location and stability is then treated by the appropriate method of casting or internal fixation. However, while this is the current standard of care for all open fractures, not all open fractures are the same and can differ in terms of the bone involved, energy causing the injury and the skeletal maturity of the patient. Children, for example, have a thick periosteum which may diminish the rate of infection and decrease the time to healing. In addition, the protocol of operative debridement was introduced at the same time as widespread antibiotic use. It is not known whether the mechanical operative management or antibiotic use has resulted in improved outcomes. In retrospective studies, centers are reporting emergency department management alone may result in equal results without the time and expense of the operative theater.
The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators hypothesize that minor open fractures in children can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. If the inclusion criteria is met and informed consent is obtained, children will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management. Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics. Both wounds will be examined at interval follow up periods for signs of infection. Outcomes evaluated will include the rate of infection, the number of return visits to the operating room, the time to bone healing, and other complications. This is a pilot study with the plan of eventually being a multicenter study evaluating open fracture care in children.
- Conditions
- Fractures, Open
- Being tested
- Formal Operative Treatment, Emergency Department Treatment
- Keywords
- Surgical Procedures, Operative, Fractures, Open, Fracture Fixation
- Medical subject headings
- Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal Operative TreatmentProcedure or surgery
Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management.
Emergency Department TreatmentProcedure or surgery
Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Formal Operative Treatment | Other | Children randomized to the formal operative management arm will be taken to the Operating Room within 24 hours for irrigation and debridement and appropriate bone management. Receives: Procedure: Formal Operative Treatment |
| Emergency Department Treatment | Other | Children in the Emergency Department Treatment arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics. Receives: Procedure: Emergency Department Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of infection
- Do patients with type one open fractures treated in the emergency department with irrigation have a non-inferior rate of infections compared to those treated in the operating room with formal irrigation and debridement? The response variable will be the presence of an infection in children with open fractures.
Measured: 2 weeks
Secondary outcomes (2)
Time to bone healing
- Do patients with type I open fractures who are treated nonoperatively have a non-inferior time to bone healing when compared to those treated operatively? The response variable will be time to clinical and radiographic fracture healing.
Measured: 24 weeks
Return visits to OR
Number of return visits to the operating room
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2010
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fractures, OpenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, University of Mississippi Medical Center, MultiCare Mary Bridge Children's Hospital & Health Center, Yale New Haven Health System Center for Healthcare Solutions, University of New Mexico Carrie Tingley Hospital, IWK Health Centre, Phoenix Children's Hospital, Children's Hospital Colorado, Nationwide Children's Hospital, Morristown Medical Center, NYUMC-Hospital for Joint Diseases, Children's Medical Center Dallas, Johns Hopkins University, Orthopaedic Institute for Children, Children's Hospital Los Angeles, St. Christopher's Hospital for Children, Children's Hospital of Orange County
- Responsible party
- Principal investigator, Joseph Janicki, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Joseph (Jay) A Janicki, MD, MS, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870064
- Sponsor's protocol ID
- 2012-13763
- Acronym
- PROOF
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2009
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang EC, Eisler J. Treatment of isolated type I open fractures: is emergent operative debridement necessary? Clin Orthop Relat Res. 2003 May;(410):289-94. doi: 10.1097/01.blo.0000063795.32430.4c.
PubMed 12771843Iobst CA, Tidwell MA, King WF. Nonoperative management of pediatric type I open fractures. J Pediatr Orthop. 2005 Jul-Aug;25(4):513-7. doi: 10.1097/01.bpo.0000158779.45226.74.
PubMed 15958906Doak J, Ferrick M. Nonoperative management of pediatric grade 1 open fractures with less than a 24-hour admission. J Pediatr Orthop. 2009 Jan-Feb;29(1):49-51. doi: 10.1097/BPO.0b013e3181901c66.
PubMed 19098646Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976 Jun;58(4):453-8.
PubMed 773941Grimard G, Naudie D, Laberge LC, Hamdy RC. Open fractures of the tibia in children. Clin Orthop Relat Res. 1996 Nov;(332):62-70. doi: 10.1097/00003086-199611000-00009.
PubMed 8913146Haasbeek JF, Cole WG. Open fractures of the arm in children. J Bone Joint Surg Br. 1995 Jul;77(4):576-81.
PubMed 7615601Skaggs DL, Kautz SM, Kay RM, Tolo VT. Effect of delay of surgical treatment on rate of infection in open fractures in children. J Pediatr Orthop. 2000 Jan-Feb;20(1):19-22.
PubMed 10641682Jones BG, Duncan RD. Open tibial fractures in children under 13 years of age--10 years experience. Injury. 2003 Oct;34(10):776-80. doi: 10.1016/s0020-1383(03)00031-7.
PubMed 14519359Jones IE, Williams SM, Dow N, Goulding A. How many children remain fracture-free during growth? a longitudinal study of children and adolescents participating in the Dunedin Multidisciplinary Health and Development Study. Osteoporos Int. 2002 Dec;13(12):990-5. doi: 10.1007/s001980200137.
PubMed 12459942
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement
- ClinicalTrials.gov ID
- NCT00870064
- Acronym / sponsor ID
- PROOF / 2012-13763
- Conditions
- Fractures, Open
- Keywords
- Surgical Procedures, Operative, Fractures, Open, Fracture Fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, University of Mississippi Medical Center, MultiCare Mary Bridge Children's Hospital & Health Center, Yale New Haven Health System Center for Healthcare Solutions, University of New Mexico Carrie Tingley Hospital, IWK Health Centre, Phoenix Children's Hospital, Children's Hospital Colorado, Nationwide Children's Hospital, Morristown Medical Center, NYUMC-Hospital for Joint Diseases, Children's Medical Center Dallas, Johns Hopkins University, Orthopaedic Institute for Children, Children's Hospital Los Angeles, St. Christopher's Hospital for Children, Children's Hospital of Orange County
- Study start
- Mar 2010 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor open fractures can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. Children who meet the study criteria will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Outcomes from each group will be evaluated and compared, including rate of infection, number of return visits to the operating room, time to union, and other complications.
Detailed description
Fractures in which bone has been exposed to the outside world through an associated skin injury, known as open fractures, are frequently encountered in orthopaedics. Traditionally, treatment calls for a formal, operative treatment in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. The bone itself, depending on the age of the patient, fracture location and stability is then treated by the appropriate method of casting or internal fixation. However, while this is the current standard of care for all open fractures, not all open fractures are the same and can differ in terms of the bone involved, energy causing the injury and the skeletal maturity of the patient. Children, for example, have a thick periosteum which may diminish the rate of infection and decrease the time to healing. In addition, the protocol of operative debridement was introduced at the same time as widespread antibiotic use. It is not known whether the mechanical operative management or antibiotic use has resulted in improved outcomes. In retrospective studies, centers are reporting emergency department management alone may result in equal results without the time and expense of the operative theater.
The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators hypothesize that minor open fractures in children can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. If the inclusion criteria is met and informed consent is obtained, children will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Children randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management. Children in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics. Both wounds will be examined at interval follow up periods for signs of infection. Outcomes evaluated will include the rate of infection, the number of return visits to the operating room, the time to bone healing, and other complications. This is a pilot study with the plan of eventually being a multicenter study evaluating open fracture care in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formal Operative Treatment | Other | Procedure: Formal Operative TreatmentChildren randomized to the formal operative management arm will be taken to the Operating Room within 24 hours for irrigation and debridement and appropriate bone management. |
| Emergency Department Treatment | Other | Procedure: Emergency Department TreatmentChildren in the Emergency Department Treatment arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- open fracture amenable to treatment by closed reduction
- low energy mechanism of injury (e.g., falls from less than 10 feet, bicycle accidents)
- wound less than 1cm in length and the bone not visualized through the skin
Key exclusion criteria (6 listed)
- open fracture not amenable to treatment by closed reduction
- open fracture that would typically require operative reduction and fixation
- high energy mechanism of injury (e.g., struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet)
- wound greater than 1cm in length
- gross contamination of wound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formal Operative TreatmentChildren randomized to the OR arm will be taken to the OR within 24 hours for irrigation and debridement and appropriate bone management. | Procedure or surgery | Formal Operative Treatment |
| Emergency Department TreatmentChildren in the ED arm will have a washout in the emergency room under conscious sedation, a closed reduction and home antibiotics. | Procedure or surgery | Emergency Department Treatment |
Primary outcome
Rate of infection
Time frame: 2 weeks
1. Do patients with type one open fractures treated in the emergency department with irrigation have a non-inferior rate of infections compared to those treated in the operating room with formal irrigation and debridement? The response variable will be the presence of an infection in children with open fractures.
2 secondary outcomes
Time to bone healing
Time frame: 24 weeks
Return visits to OR
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 12771843Yang EC, Eisler J. Treatment of isolated type I open fractures: is emergent operative debridement necessary? Clin Orthop Relat Res. 2003 May;(410):289-94. doi: 10.1097/01.blo.0000063795.32430.4c.
- Background: PubMed 15958906Iobst CA, Tidwell MA, King WF. Nonoperative management of pediatric type I open fractures. J Pediatr Orthop. 2005 Jul-Aug;25(4):513-7. doi: 10.1097/01.bpo.0000158779.45226.74.
- Background: PubMed 19098646Doak J, Ferrick M. Nonoperative management of pediatric grade 1 open fractures with less than a 24-hour admission. J Pediatr Orthop. 2009 Jan-Feb;29(1):49-51. doi: 10.1097/BPO.0b013e3181901c66.
- Background: PubMed 773941Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976 Jun;58(4):453-8.
- Background: PubMed 8913146Grimard G, Naudie D, Laberge LC, Hamdy RC. Open fractures of the tibia in children. Clin Orthop Relat Res. 1996 Nov;(332):62-70. doi: 10.1097/00003086-199611000-00009.
- Background: PubMed 7615601Haasbeek JF, Cole WG. Open fractures of the arm in children. J Bone Joint Surg Br. 1995 Jul;77(4):576-81.
- Background: PubMed 10641682Skaggs DL, Kautz SM, Kay RM, Tolo VT. Effect of delay of surgical treatment on rate of infection in open fractures in children. J Pediatr Orthop. 2000 Jan-Feb;20(1):19-22.
- Background: PubMed 14519359Jones BG, Duncan RD. Open tibial fractures in children under 13 years of age--10 years experience. Injury. 2003 Oct;34(10):776-80. doi: 10.1016/s0020-1383(03)00031-7.
- Background: PubMed 12459942Jones IE, Williams SM, Dow N, Goulding A. How many children remain fracture-free during growth? a longitudinal study of children and adolescents participating in the Dunedin Multidisciplinary Health and Development Study. Osteoporos Int. 2002 Dec;13(12):990-5. doi: 10.1007/s001980200137.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph (Jay) A Janicki, MD, MS principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formal Operative Treatment and Emergency Department Treatment in people with Fractures, Open, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie K Burgess, PhD, CCRP (312-227-6531, jburgess@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of infection (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870064, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.