NCT01264146

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

1.6 years

First QC Date

December 17, 2010

Last Update Submit

November 26, 2012

Conditions

MicrocirculationWound Healing

Keywords

hyperbaric oxygen therapycalcaneal fracturecalcaneal platingwound infectionmicrocirculation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Effect of HBOT on postoperative microcirculation of the foot, clinical outcome

    2 years

Study Arms (2)

calcaneal plating HBOT

ACTIVE COMPARATOR

Open reduction and internal fixation of calcaneal fracture + HBOT

Procedure: HBOT

calcaneal plating

PLACEBO COMPARATOR

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

Procedure: Placebo (Sham)

Interventions

HBOTPROCEDURE

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

Also known as: calcaneal plating, hyperbaric oxygen therapy
calcaneal plating HBOT
Placebo (Sham)PROCEDURE

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

Also known as: calcaneal plating, Sham procedure (HBOT)
calcaneal plating

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute displaced intraarticular calcaneal fracture

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RWTH Aachen University

Aachen, 52074, Germany

Location

Related Publications (2)

  • 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.

    PMID: 39289760DERIVED

  • 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.

    PMID: 34357432DERIVED

MeSH Terms

Conditions

Wound Infection

Interventions

Hyperbaric Oxygenationsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Matthias Knobe, MD

    Dpt. of Orthopedic Trauma, RWTH Aachen University

    PRINCIPAL INVESTIGATOR

  • Hans-Christoph Pape, MD

    Dpt. of Orthopedic Trauma, RWTH Aachen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2010

First Posted

December 21, 2010

Study Start

April 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

DE(1)