Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate?

Study Overview
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Brief Summary
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This study aims to test the hypothesis that postoperative daily hyperbaric oxygen therapy (HBOT) decreases soft-tissue complication rate during the operative handling of intra-articular calcaneal fractures. Minor motivations: 1. To evaluate microcirculatory criteria of cutaneous tissue predicting emerging wound healing defects, 2. To identify patients at risk for soft-tissue complication after calcaneal plate osteosynthesis and to determine the optimal time point for operative intervention using these microcirculatory criteria preoperatively, 3. To evaluate the effect of HBOT on postoperative microcirculation, 4. To collect preliminary data to evaluate the economical impact of wound complications, with and without HBOT, 5. To identify a correlation between HBOT with expected limited soft-tissue complication rate and the clinical and radiographic outcome two years after surgery.

Detailed Description
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Wound complication remains an important problem in calcaneal fractures, with some plate series quoting up to a 27% infection rate. The original hypothesis stimulating this study is that HBOT after calcaneal plating can decrease such high rates of infection. Validation of this hypothesis would not only alter guidelines for standard procedure (plate osteosynthesis), but would also help to avoid difficult follow-up operations and improve functional outcome after calcaneal fracture. To date, this therapeutic approach has not been systematically tested in the existing literature. As further motivation for this study, the assessment of the existent microcirculation as a potential screening parameter will be analysed. In order to do so, it is assumed that wound infection partially develops due to disruptions in the microcirculation. This leads to the hypotheses, that by measuring the microcirculation, patients at high risk for post operative infections could be identified before operation, planning a different less invasive approach or conservative treatment.

Official Title
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Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate?

Conditions
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Microcirculation, Wound Healing

Intervention / Treatment
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* Procedure: HBOT
* Procedure: Placebo (Sham)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute displaced intraarticular calcaneal fracture Exclusion Criteria: Extraarticular or open fracture, re-fracture or past surgical procedures in calcaneal region, peripheral vascular disease, insulin dependent diabetes mellitus, macroangiopathy: Study population is representative for all calcaneal fractures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: calcaneal plating HBOT<br>Open reduction and internal fixation of calcaneal fracture + HBOT | Procedure: HBOT<br>* Open reduction and internal fixation of calcaneal fracture + hyperbaric oxygen therapy 20 postoperative days (one time, 90 minutes a day)<br>* Other names: hyperbaric oxygen therapy;|
| Placebo Comparator: calcaneal plating<br>Open reduction and internal fixation of calcaneal fracture + Placebo (Sham) | Procedure: Placebo (Sham)<br>* open reduction and internal fixation of calcaneal fracture + Placebo (Sham)<br>* Other names: Sham procedure (HBOT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative rate of wound complication after calcaneal plating | Rate of postoperative wound edge necrosis and superficial or deep infection determined by wound redness, secretion of pus, detection of a microbial agens, CRP elevation and detection of fluid by sonography. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of HBOT on postoperative microcirculation of the foot, clinical outcome | Complications later than day 20 post-surgery, clinical and radiographic outcome (2years follow-up), To evaluate microcirculatory criteria of cutaneous tissue, To identify patients at risk for soft-tissue complication after calcaneal plate osteosynthesis and to determine the optimal time point for operative intervention, To evaluate the effect of HBOT on postoperative microcirculation, To identify a correlation between HBOT with expected limited soft-tissue complication rate and the clinical and radiographic outcome two years after surgery. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperbaric oxygen therapy, calcaneal fracture, calcaneal plating, wound infection, microcirculation