Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate? (HOCIF)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Microcirculation Wound Healing |
Procedure: HBOT Procedure: Placebo (Sham) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate? |
- Postoperative rate of wound complication after calcaneal plating [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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.
- Effect of HBOT on postoperative microcirculation of the foot, clinical outcome [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 20 |
| Study Start Date: | April 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: calcaneal plating HBOT
Open reduction and internal fixation of calcaneal fracture + HBOT
|
Procedure: HBOT
Open reduction and internal fixation of calcaneal fracture + hyperbaric oxygen therapy 20 postoperative days (one time, 90 minutes a day)
Other Names:
|
|
Placebo Comparator: calcaneal plating
Open reduction and internal fixation of calcaneal fracture + Placebo (Sham)
|
Procedure: Placebo (Sham)
open reduction and internal fixation of calcaneal fracture + Placebo (Sham)
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Germany | |
| RWTH Aachen University | |
| Aachen, Germany, 52074 | |
| Principal Investigator: | Matthias Knobe, MD | Dpt. of Orthopedic Trauma, RWTH Aachen University |
| Study Chair: | Hans-Christoph Pape, MD | Dpt. of Orthopedic Trauma, RWTH Aachen University |
More Information
No publications provided
| Responsible Party: | RWTH Aachen University |
| ClinicalTrials.gov Identifier: | NCT01264146 History of Changes |
| Other Study ID Numbers: | CTC-A10-025 |
| Study First Received: | December 17, 2010 |
| Last Updated: | November 26, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by RWTH Aachen University:
|
hyperbaric oxygen therapy calcaneal fracture calcaneal plating wound infection microcirculation |
Additional relevant MeSH terms:
|
Intra-Articular Fractures Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013