Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate? (HOCIF)
Primary Purpose
Microcirculation, Wound Healing
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HBOT
Placebo (Sham)
Sponsored by
About this trial
This is an interventional treatment trial for Microcirculation focused on measuring hyperbaric oxygen therapy, calcaneal fracture, calcaneal plating, wound infection, microcirculation
Eligibility 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
Sites / Locations
- RWTH Aachen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
calcaneal plating HBOT
calcaneal plating
Arm Description
Open reduction and internal fixation of calcaneal fracture + HBOT
Open reduction and internal fixation of calcaneal fracture + Placebo (Sham)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01264146
First Posted
December 17, 2010
Last Updated
November 26, 2012
Sponsor
RWTH Aachen University
1. Study Identification
Unique Protocol Identification Number
NCT01264146
Brief Title
Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate?
Acronym
HOCIF
Official Title
Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microcirculation, Wound Healing
Keywords
hyperbaric oxygen therapy, calcaneal fracture, calcaneal plating, wound infection, microcirculation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
calcaneal plating HBOT
Arm Type
Active Comparator
Arm Description
Open reduction and internal fixation of calcaneal fracture + HBOT
Arm Title
calcaneal plating
Arm Type
Placebo Comparator
Arm Description
Open reduction and internal fixation of calcaneal fracture + Placebo (Sham)
Intervention Type
Procedure
Intervention Name(s)
HBOT
Other Intervention Name(s)
calcaneal plating, hyperbaric oxygen therapy
Intervention Description
Open reduction and internal fixation of calcaneal fracture + hyperbaric oxygen therapy 20 postoperative days (one time, 90 minutes a day)
Intervention Type
Procedure
Intervention Name(s)
Placebo (Sham)
Other Intervention Name(s)
calcaneal plating, Sham procedure (HBOT)
Intervention Description
open reduction and internal fixation of calcaneal fracture + Placebo (Sham)
Primary Outcome Measure Information:
Title
Postoperative rate of wound complication after calcaneal plating
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Effect of HBOT on postoperative microcirculation of the foot, clinical outcome
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Knobe, MD
Organizational Affiliation
Dpt. of Orthopedic Trauma, RWTH Aachen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans-Christoph Pape, MD
Organizational Affiliation
Dpt. of Orthopedic Trauma, RWTH Aachen University
Official's Role
Study Chair
Facility Information:
Facility Name
RWTH Aachen University
City
Aachen
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34357432
Citation
Knobe M, Iselin LD, van de Wall BJM, Lichte P, Hildebrand F, Beeres FJP, Link BC, Gueorguiev B, Nebelung S, Ganse B, Migliorini F, Klos K, Babst R, Haefeli PC. Reduced pre-operative skin oxygen saturation predicts revision after open reduction and internal fixation in calcaneal fractures : A reduced pre-operative oxygen saturation as measured by laser-Doppler spectrophotometry in 8 mm depth is associated with revision surgery after open reduction and internal fixation of calcaneal fractures through an extended lateral approach. Int Orthop. 2021 Sep;45(9):2355-2363. doi: 10.1007/s00264-021-05157-4. Epub 2021 Aug 6.
Results Reference
derived
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Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate?
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