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

Sponsor

RWTH Aachen University (Other)

Overall Status

Completed

CT.gov ID

NCT01264146

Collaborator

(none)

Enrollment

Location

Arms

19.1

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Microcirculation Wound Healing	Procedure: HBOT Procedure: Placebo (Sham)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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: 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)

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:

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)

Outcome Measures

Primary Outcome Measures

Postoperative rate of wound complication after calcaneal plating [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.

Secondary Outcome Measures

Effect of HBOT on postoperative microcirculation of the foot, clinical outcome [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	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