Fractures, ComminutedPhase 2/3NCT01693484
Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures
A Phase 2/3 study testing ICG (Indocyanine Green) in people with Fractures, Comminuted and Surgical Wound Dehiscence, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to learn if patterns of blood-flow around the incision site of patients undergoing surgery for heel-bone fractures can help predict whether complications will arise after a specific type of operation.The goals of this research… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fractures, Comminuted, Surgical Wound Dehiscence, Necrosis
- What is being tested?
- ICG (Indocyanine Green)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Mar 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons 18-65 years of age with closed unilateral operative Calcaneus fractures that may be approached by an extended lateral incision
Who cannot join
- Patients declining participation
- Patients with vascular disease or injury requiring vascular repair
- Patients that have undergone prior ankle or hindfoot surgery
- Patients with additional hindfoot injury or injuries
- Patients with open calcaneal fracture
- Patients with head injury
Show all 9Show fewer
- Patients with injury greater than 3 weeks old
- Patients who are pregnant or currently nursing
- Patients who are incapable of personally understanding the informed consent document due to mental incapacitation or inability to speak and understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71103
About this study
Official title: Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures Requiring Extensile Lateral Incision
Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to learn if patterns of blood-flow around the incision site of patients undergoing surgery for heel-bone fractures can help predict whether complications will arise after a specific type of operation.The goals of this research study are to effectively answer as many of the following research questions as possible:
- Can a drug normally used to evaluate adequate blood flow in plastic surgery and tissue transfer be used to identify altered patterns of blood flow at the operative site of Calcaneus fractures, when compared to the uninjured extremity?
- Are changes in blood flow identifiable at the operative site post operatively?
- Are there certain patterns of blood flow present preoperatively or postoperatively that can predict wound complication?
- Can certain patterns of blood flow predict the location of slough or dehiscence after surgery?
- Does the incision site and its proximity to specific patterns of blood flow possibly predict wound complication?
The hypothesis is that the study drug will show a correlation between certain patterns of blood flow and whatever post-operative complications may arise.
Read the detailed description
Fractures of the calcaneus comprise 2% of all adult fractures. These fractures make up 60% of all tarsal injuries, the majority of which are closed, displaced intra-articular fractures. Despite the injury's prevalence, dispute over the appropriate method of treatment remains ongoing. Several studies have shown that an open, surgical approach is superior to either a non-surgical or percutaneous approach with regard to restoring proper alignment and structure of the hindfoot, depending on the severity of the displacement, and provided that certain patient conditions do not preclude surgery. Adequately restoring hindfoot structure is paramount to good clinical outcome; not only is proper alignment integral for fully recovering physiological functionality, but also in preventing further complications such as subtalar arthritis that present commonly in malunited calcaneal fractures.
Though literature may show that open reduction and internal fixation (ORIF) techniques provide a better long term outcome of severely displaced intra-articular fractures, proponents of both non surgical and percutaneous approaches argue that the superiority of the outcome may be mitigated by the fact that open surgical procedures are laden post operatively with numerous wound complications. These complications include, but are not limited to, both deep and superficial infections resulting in slough, dehiscence, necrosis, and erythema in and around the surgical site. Managing infections of the surrounding soft tissue and vasculature of the calcaneus following operative treatment indeed seems to present a great challenge to treating physicians, with wound healing complications present in 2-25% of cases.
A necessity for surgical wound repair is adequately vascularized tissue, which can be difficult to come by during closure of the wound due to the undermining and displacement of soft tissue during surgery. Sufficiently perfused soft tissue can also be difficult to differentiate from tissues that are inadequately vascular based on traditional clinical criteria such as color, warmth, and dermal bleeding. The degree of this avascularity can depend on many factors relating to the patient, necessitating studies be conducted identifying what factors place a prospective patient at a higher risk for developing wound healing problems post operatively. Studies of this nature thus far have noted that factors such as age, sex, height, weight, Bohler's angle, tobacco usage, and pre-existing conditions such as diabetes, vascular disease, and immune deficiencies may be indicative of increased likelihood for developing post surgical complications. Another risk factor of particular interest is the timing of surgery after the incidence of injury. Current literature regarding treatment of hindfoot injuries shows a moderate degree of uniformity, advocating a delay in operative measures until the soft tissue swelling around the injury has had time to subside: a window of approximately 7-14 days after injury. Additionally, in their investigation of Bohler's angle as a predictor for wound healing complications, Shuler and colleagues noted the pre and post operative Bohler's angle differential to be a significant predictor of developing infections, postulating that the increase in heel height during surgery may concomitantly increase soft tissue tension substantially enough to disrupt proper blood supply to the surgical site during healing. These findings lend tremendous support to the idea that blood perfusion in soft tissue plays a significant role in predicting wound healing complications. However, to our knowledge, the use of angiography to correlate pre and post operative soft tissue perfusion patterns with post operative complication in patients undergoing ORIF of fractured calcanei has never been investigated.
Indocyanine green (ICG) angiography has been utilized in a myriad of other fields of medicine to evaluate perfusion in different tissues. It has been used in cardiac surgery to asses bypass patency, in microsurgery to assist in free tissue transfers, and in plastic surgery to assess areas of future necrosis during mastectomy operations. Recently, ICG angiography has been used in general surgery to detect ischemic tissues and aid surgeons in determining the appropriate extent of debridement necessary prior to wound closure in laparotomy procedures. Though its utility in other disciplines of medicine are currently being further developed and understood, the implications of ICG angiography in orthopaedic surgery have gone unrecognized. We postulate that soft-tissue perfusion patterns elucidated by ICG angiography in the heels of patients that have incurred calcaneal fractures may be predictive of wound healing complications that develop after surgery. This information could allow surgeons to greatly reduce the complication rate of open reduction procedures on calcaneus fractures by early utilization of appropriate, patient specific prophylactic measures, and could provide an additional contraindication to this operation for patients whom otherwise were not aware they are at an elevated risk.
- Conditions
- Fractures, Comminuted, Surgical Wound Dehiscence, Necrosis
- Being tested
- ICG (Indocyanine Green)
- Keywords
- Calcaneus, Fracture, Indocyanine Green, Angiography, Open Reduction and Internal Fixation
- Medical subject headings
- Fractures, Comminuted, Surgical Wound Dehiscence, Necrosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG (Indocyanine Green)Drug
Also called NDC # 75874-0701-25
Diagnostic drug used for visualisation of blood perfusion in various tissues.Administered intravenously, 2X: 1X prior to anesthesia, and 1X after tourniquet on operative extremity has been released for at least 15 minutes. When excited by laser light source, it subsequently emits at a near infrared frequency.
| Study group | Role | What they receive |
|---|---|---|
| ICG administered | Experimental | The ICG dose (10 mg/4cc per image capture) will be administered in its entirety via push injection through IV access established for standard surgical procedure, followed by 10 cc Normal Saline bolus. This ICG dose will be administered twice, 1X prior to anesthesia, and 1X after the tourniquet on operative extremity has been removed for at least 15 minutes. Receives: Drug: ICG (Indocyanine Green) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion Data Infection Wound Healing Complication
correlation of multiple absolute and relative data points acquired from near infra red spectroscopy compared to clinical postoperative infection or wound healing complication following lateral approach calcaneus fracture
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Resource availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fractures, ComminutedStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Jaeblon, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Todd D Jaeblon, D.O, Principal investigator, Associate Professor of Orthopaedic Surgery; Associate Director of Orthopaedic Traruma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693484
- Sponsor's protocol ID
- ICGVA-OS CALCIS 2012
- Status last verified
- May 2017
- First submitted
- 20 Sep 2012
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures Requiring Extensile Lateral Incision
- ClinicalTrials.gov ID
- NCT01693484
- Acronym / sponsor ID
- ICGVA-OS CALCIS 2012
- Conditions
- Fractures, Comminuted, Surgical Wound Dehiscence, Necrosis
- Keywords
- Calcaneus, Fracture, Indocyanine Green, Angiography, Open Reduction and Internal Fixation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resource availability
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Posted 24 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to learn if patterns of blood-flow around the incision site of patients undergoing surgery for heel-bone fractures can help predict whether complications will arise after a specific type of operation.The goals of this research study are to effectively answer as many of the following research questions as possible:
- Can a drug normally used to evaluate adequate blood flow in plastic surgery and tissue transfer be used to identify altered patterns of blood flow at the operative site of Calcaneus fractures, when compared to the uninjured extremity?
- Are changes in blood flow identifiable at the operative site post operatively?
- Are there certain patterns of blood flow present preoperatively or postoperatively that can predict wound complication?
- Can certain patterns of blood flow predict the location of slough or dehiscence after surgery?
- Does the incision site and its proximity to specific patterns of blood flow possibly predict wound complication?
The hypothesis is that the study drug will show a correlation between certain patterns of blood flow and whatever post-operative complications may arise.
Detailed description
Fractures of the calcaneus comprise 2% of all adult fractures. These fractures make up 60% of all tarsal injuries, the majority of which are closed, displaced intra-articular fractures. Despite the injury's prevalence, dispute over the appropriate method of treatment remains ongoing. Several studies have shown that an open, surgical approach is superior to either a non-surgical or percutaneous approach with regard to restoring proper alignment and structure of the hindfoot, depending on the severity of the displacement, and provided that certain patient conditions do not preclude surgery. Adequately restoring hindfoot structure is paramount to good clinical outcome; not only is proper alignment integral for fully recovering physiological functionality, but also in preventing further complications such as subtalar arthritis that present commonly in malunited calcaneal fractures.
Though literature may show that open reduction and internal fixation (ORIF) techniques provide a better long term outcome of severely displaced intra-articular fractures, proponents of both non surgical and percutaneous approaches argue that the superiority of the outcome may be mitigated by the fact that open surgical procedures are laden post operatively with numerous wound complications. These complications include, but are not limited to, both deep and superficial infections resulting in slough, dehiscence, necrosis, and erythema in and around the surgical site. Managing infections of the surrounding soft tissue and vasculature of the calcaneus following operative treatment indeed seems to present a great challenge to treating physicians, with wound healing complications present in 2-25% of cases.
A necessity for surgical wound repair is adequately vascularized tissue, which can be difficult to come by during closure of the wound due to the undermining and displacement of soft tissue during surgery. Sufficiently perfused soft tissue can also be difficult to differentiate from tissues that are inadequately vascular based on traditional clinical criteria such as color, warmth, and dermal bleeding. The degree of this avascularity can depend on many factors relating to the patient, necessitating studies be conducted identifying what factors place a prospective patient at a higher risk for developing wound healing problems post operatively. Studies of this nature thus far have noted that factors such as age, sex, height, weight, Bohler's angle, tobacco usage, and pre-existing conditions such as diabetes, vascular disease, and immune deficiencies may be indicative of increased likelihood for developing post surgical complications. Another risk factor of particular interest is the timing of surgery after the incidence of injury. Current literature regarding treatment of hindfoot injuries shows a moderate degree of uniformity, advocating a delay in operative measures until the soft tissue swelling around the injury has had time to subside: a window of approximately 7-14 days after injury. Additionally, in their investigation of Bohler's angle as a predictor for wound healing complications, Shuler and colleagues noted the pre and post operative Bohler's angle differential to be a significant predictor of developing infections, postulating that the increase in heel height during surgery may concomitantly increase soft tissue tension substantially enough to disrupt proper blood supply to the surgical site during healing. These findings lend tremendous support to the idea that blood perfusion in soft tissue plays a significant role in predicting wound healing complications. However, to our knowledge, the use of angiography to correlate pre and post operative soft tissue perfusion patterns with post operative complication in patients undergoing ORIF of fractured calcanei has never been investigated.
Indocyanine green (ICG) angiography has been utilized in a myriad of other fields of medicine to evaluate perfusion in different tissues. It has been used in cardiac surgery to asses bypass patency, in microsurgery to assist in free tissue transfers, and in plastic surgery to assess areas of future necrosis during mastectomy operations. Recently, ICG angiography has been used in general surgery to detect ischemic tissues and aid surgeons in determining the appropriate extent of debridement necessary prior to wound closure in laparotomy procedures. Though its utility in other disciplines of medicine are currently being further developed and understood, the implications of ICG angiography in orthopaedic surgery have gone unrecognized. We postulate that soft-tissue perfusion patterns elucidated by ICG angiography in the heels of patients that have incurred calcaneal fractures may be predictive of wound healing complications that develop after surgery. This information could allow surgeons to greatly reduce the complication rate of open reduction procedures on calcaneus fractures by early utilization of appropriate, patient specific prophylactic measures, and could provide an additional contraindication to this operation for patients whom otherwise were not aware they are at an elevated risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG administered | Experimental | Drug: ICG (Indocyanine Green)The ICG dose (10 mg/4cc per image capture) will be administered in its entirety via push injection through IV access established for standard surgical procedure, followed by 10 cc Normal Saline bolus. This ICG dose will be administered twice, 1X prior to anesthesia, and 1X after the tourniquet on operative extremity has been removed for at least 15 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons 18-65 years of age with closed unilateral operative Calcaneus fractures that may be approached by an extended lateral incision
Key exclusion criteria (9 listed)
- Patients declining participation
- Patients with vascular disease or injury requiring vascular repair
- Patients that have undergone prior ankle or hindfoot surgery
- Patients with additional hindfoot injury or injuries
- Patients with open calcaneal fracture
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 |
|---|---|---|
| ICG (Indocyanine Green)Also: NDC # 75874-0701-25Diagnostic drug used for visualisation of blood perfusion in various tissues.Administered intravenously, 2X: 1X prior to anesthesia, and 1X after tourniquet on operative extremity has been released for at least 15 minutes. When excited by laser light source, it subsequently emits at a near infrared frequency. | Drug | ICG administered |
Primary outcome
Perfusion Data Infection Wound Healing Complication
Time frame: 3 months postoperative
correlation of multiple absolute and relative data points acquired from near infra red spectroscopy compared to clinical postoperative infection or wound healing complication following lateral approach calcaneus fracture
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Todd D Jaeblon, D.O principal investigator
Associate Professor of Orthopaedic Surgery; Associate Director of Orthopaedic Traruma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ICG (Indocyanine Green) in people with Fractures, Comminuted and Surgical Wound Dehiscence, run by Louisiana State University Health Sciences Center Shreveport 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Jun 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Perfusion Data Infection Wound Healing Complication (time frame: 3 months postoperative). 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 20 Jun 2017.