Clinical Trials Logo

Clinical 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 study are to effectively answer as many of the following research questions as possible:

1. 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?

2. Are changes in blood flow identifiable at the operative site post operatively?

3. Are there certain patterns of blood flow present preoperatively or postoperatively that can predict wound complication?

4. Can certain patterns of blood flow predict the location of slough or dehiscence after surgery?

5. 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.


Clinical Trial 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01693484
Study type Interventional
Source Louisiana State University Health Sciences Center Shreveport
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date April 2013
Completion date March 2015

See also
  Status Clinical Trial Phase
Terminated NCT00654641 - Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy N/A
Recruiting NCT04920253 - Real World Evidence With the Debritom+ TM Novel Micro Water Jet Technology at a Single Wound Center N/A
Terminated NCT01679678 - A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen Phase 2
Completed NCT01050673 - Trial of Versajet Compared With Conventional Treatment in Acute and Chronic Wounds N/A
Terminated NCT01083472 - Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR) Phase 4
Terminated NCT00260494 - Acupuncture and Post-Surgical Wound Healing N/A
Active, not recruiting NCT04257097 - Reinforced PTFE Meshes Versus Customized Titanium Meshes N/A
Not yet recruiting NCT04894604 - A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions N/A
Completed NCT03293862 - Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies N/A
Completed NCT01658163 - Use of 2-octyl-cyanoacrylate Together With a Self-adhering Mesh N/A
Completed NCT05716490 - Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy N/A
Enrolling by invitation NCT02581904 - Prevena Vascular Groin Wound Study Phase 4
Recruiting NCT02280733 - A Real World, Observational Registry of Chronic Wounds and Ulcers
Recruiting NCT02467998 - Negative Pressure Wound Therapy Registry
Recruiting NCT02322554 - Cellular and Tissue Based Therapy Registry
Completed NCT02453165 - Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Closure N/A
Completed NCT04286334 - Three-dimensional Bone Regeneration Using Custom-made Meshes With and Without Collagen Membrane N/A
Completed NCT02879487 - Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy N/A
Completed NCT02565043 - The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds N/A