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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: RWTH Aachen University

Current Primary Outcome: Postoperative rate of wound complication after calcaneal plating [ Time Frame: 30 days ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Effect of HBOT on postoperative microcirculation of the foot, clinical outcome [ Time Frame: 2 years ]

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.


Original Secondary Outcome: Same as current

Information By: RWTH Aachen University

Dates:
Date Received: December 17, 2010
Date Started: April 2011
Date Completion:
Last Updated: November 26, 2012
Last Verified: November 2012