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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01264146
First received: December 17, 2010
Last updated: November 26, 2012
Last verified: November 2012
  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?

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:
  • calcaneal plating
  • hyperbaric oxygen therapy
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:
  • calcaneal plating
  • Sham procedure (HBOT)

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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01264146

Locations
Germany
RWTH Aachen University
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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 July 22, 2014