Type II and IIa Open Tibia FracturesNCT01315392
A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures
A study testing delayed closure and immediate wound closure in people with Type II and IIa Open Tibia Fractures, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Type II and IIa Open Tibia Fractures
- What is being tested?
- delayed closure and immediate wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gustilo type II-IIIa tibia fracture
- age greater than 15 years
- fractures amenable to intramedullary nailing
Who cannot join
- excessive wound contamination
- patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention
- impaired or absent consciousness
- refusal of consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
Official title: A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study
Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.
- Conditions
- Type II and IIa Open Tibia Fractures
- Being tested
- delayed closure, immediate wound closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed closureProcedure or surgery
wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for a second debridement and definitive closure.
immediate wound closureProcedure or surgery
traumatic and surgical wounds closed at the initial surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| delayed closure | Active comparator | wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for debridement and definitive closure. Receives: Procedure: delayed closure |
| immediate wound closure | Active comparator | traumatic and surgical wounds closed at initial surgical intervention Receives: Procedure: immediate wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection rate
defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.
hospital readmissions
need for additional procedures and hospital readmissions related to the index injury will be documented
tibial fracture healing
evidence of bridging callus on three of four cortices assessed by biplanar radiograph
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II and IIa Open Tibia FracturesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Intervention model
- Parallel groups
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Orthopaedic Research and Education Fund
- Responsible party
- Sponsor
- Investigators
- Michael J Bosse, MD, Principal investigator, Carolians HealthCare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315392
- Sponsor's protocol ID
- OTAOREF2000MJB
- Status last verified
- Mar 2011
- First submitted
- 1 Mar 2011
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study
- ClinicalTrials.gov ID
- NCT01315392
- Acronym / sponsor ID
- OTAOREF2000MJB
- Conditions
- Type II and IIa Open Tibia Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Orthopaedic Research and Education Fund
- Study start
- Jul 2000
- First posted
- 15 Mar 2011 (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.
Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delayed closure | Active comparator | Procedure: delayed closurewounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for debridement and definitive closure. |
| immediate wound closure | Active comparator | Procedure: immediate wound closuretraumatic and surgical wounds closed at initial surgical intervention |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gustilo type II-IIIa tibia fracture
- age greater than 15 years
- fractures amenable to intramedullary nailing
Key exclusion criteria (4 listed)
- excessive wound contamination
- patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention
- impaired or absent consciousness
- refusal of consent
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 |
|---|---|---|
| delayed closurewounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for a second debridement and definitive closure. | Procedure or surgery | delayed closure |
| immediate wound closuretraumatic and surgical wounds closed at the initial surgical intervention | Procedure or surgery | immediate wound closure |
Primary outcome
infection rate
defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.
hospital readmissions
need for additional procedures and hospital readmissions related to the index injury will be documented
tibial fracture healing
evidence of bridging callus on three of four cortices assessed by biplanar radiograph
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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. This study is not recruiting at the moment.
Michael J Bosse, MD principal investigator
Carolians HealthCare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delayed closure and immediate wound closure in people with Type II and IIa Open Tibia Fractures, run by Wake Forest University Health Sciences 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 4 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: finished, as of the sponsor's last update on 21 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection rate. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2022.