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

NCT ID: NCT01264146

Last Updated: 2012-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-11-30

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.

Conditions

Microcirculation; Wound Healing

Keywords

hyperbaric oxygen therapy; calcaneal fracture; calcaneal plating; wound infection; microcirculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

calcaneal plating HBOT

Open reduction and internal fixation of calcaneal fracture + HBOT

Group Type: ACTIVE_COMPARATOR

HBOT

Intervention Type: PROCEDURE

Open reduction and internal fixation of calcaneal fracture + hyperbaric oxygen therapy 20 postoperative days (one time, 90 minutes a day)

calcaneal plating

Open reduction and internal fixation of calcaneal fracture + Placebo (Sham)

Group Type: PLACEBO_COMPARATOR

Placebo (Sham)

Intervention Type: PROCEDURE

open reduction and internal fixation of calcaneal fracture + Placebo (Sham)

Interventions

HBOT

Open reduction and internal fixation of calcaneal fracture + hyperbaric oxygen therapy 20 postoperative days (one time, 90 minutes a day)

Intervention Type: PROCEDURE

Placebo (Sham)

open reduction and internal fixation of calcaneal fracture + Placebo (Sham)

Intervention Type: PROCEDURE

Other Intervention Names

calcaneal plating; hyperbaric oxygen therapy; calcaneal plating; Sham procedure (HBOT)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Knobe, MD

Role: PRINCIPAL_INVESTIGATOR

Dpt. of Orthopedic Trauma, RWTH Aachen University

Hans-Christoph Pape, MD

Role: STUDY_CHAIR

Dpt. of Orthopedic Trauma, RWTH Aachen University

Locations

RWTH Aachen University

Aachen, , Germany

Countries

Germany

References

Lichte P, Blasius FM, Ganse B, Gueorguiev B, Pastor T, Nebelung S, Migliorini F, Klos K, Modabber A, Scaglioni MF, Schopper C, Hildebrand F, Knobe M. Intraoperative pneumatic tourniquet application reduces soft-tissue microcirculation, but without affecting wound healing in calcaneal fractures. Eur J Med Res. 2024 Sep 17;29(1):462. doi: 10.1186/s40001-024-01996-0.

Reference Type: DERIVED

PMID: 39289760 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34357432 (View on PubMed)

Other Identifiers

CTC-A10-025

Identifier Type: -

Identifier Source: org_study_id