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

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing; Microcirculation
• Intervention / Treatment: Procedure: HBOT; Procedure: Placebo (Sham)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • RWTH Aachen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: hyperbaric oxygen therapy; calcaneal plating
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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RWTH Aachen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: December 17, 2010
• First Submitted That Met QC Criteria: December 19, 2010
• First Posted (ESTIMATE): December 21, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: microcirculation; wound infection; hyperbaric oxygen therapy; calcaneal fracture; calcaneal plating
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Intra-Articular Fractures
• Other Study ID Numbers: CTC-A10-025