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Preoperative Treatment of Malleolar Fractures

Primary Purpose

Ankle Fractures, Intermittent Pneumatic Compression, Comparative Study

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Flowtron ACS800
Bandage
Sponsored by
Hospital of Southern Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Malleolar fracture requiring surgery.

Exclusion Criteria:

  • Severe arteriosclerosis.
  • Known or suspected acute DVT or flebit.
  • Severe decompensated heart failure.
  • Pulmonary embolism.
  • Acute skin conditions as dermatitis, infected wounds or recent skintransplant.
  • Open fracture.
  • Inability and/or unable to comply with treatment regime and/or to attend postoperative ambulatory follow-up.
  • Pregnancy.

Sites / Locations

  • Jesper O. SchønnemannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPC and bandage

Bandage only

Arm Description

Pneumatic device and bandage

Bandage only

Outcomes

Primary Outcome Measures

Time from diagnosis-to-surgery

Secondary Outcome Measures

Full Information

First Posted
April 28, 2015
Last Updated
August 17, 2016
Sponsor
Hospital of Southern Jutland
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1. Study Identification

Unique Protocol Identification Number
NCT02444468
Brief Title
Preoperative Treatment of Malleolar Fractures
Official Title
A Randomized Study of In-cast Intermittent Pneumatic Foot-compression in the Preoperative Treatment of Malleolar Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital of Southern Jutland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby preventing delay of surgery due to swelling. The investigators will include patients with malleolar fractures that require surgery in two groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.
Detailed Description
Malleolar fractures are often complicated by tissue swelling due to soft tissue injury, haemorrhage and secondary inflammation. This can lead to severe oedema which can compromise the ability to perform surgery due to blister formation or the inability to close the skin after surgery. Studies have shown that the use of intermittent pneumatic foot-compression (IPC) can reduce waiting time from diagnosis to surgery as well as reduce length of hospital stay. Purpose of the study is in a randomized study to investigate whether patients requiring surgery because of malleolar fractures has a lower diagnosis-to-surgery time when using IPC than patients not using IPC. All patients age 18 or above admitted to our hospital with malleolar fractures (AO type 44-A, 44-B, 44-C) requiring surgery, will be randomized to either in-cast IPC or only cast-immobilization. Time from diagnosis of the fracture(time of the x-ray) until start of surgery(time of incision) will be the primary outcome. Patients will be seen in a postoperative ambulatory follow-up at 14 days, 6 weeks, 3 months and 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures, Intermittent Pneumatic Compression, Comparative Study, Preoperative Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPC and bandage
Arm Type
Experimental
Arm Description
Pneumatic device and bandage
Arm Title
Bandage only
Arm Type
Active Comparator
Arm Description
Bandage only
Intervention Type
Device
Intervention Name(s)
Flowtron ACS800
Intervention Description
Flowtron ACS800 and bandage
Intervention Type
Other
Intervention Name(s)
Bandage
Intervention Description
Bandage only
Primary Outcome Measure Information:
Title
Time from diagnosis-to-surgery
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Malleolar fracture requiring surgery. Exclusion Criteria: Severe arteriosclerosis. Known or suspected acute DVT or flebit. Severe decompensated heart failure. Pulmonary embolism. Acute skin conditions as dermatitis, infected wounds or recent skintransplant. Open fracture. Inability and/or unable to comply with treatment regime and/or to attend postoperative ambulatory follow-up. Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper O Schønnemann, Dr
Phone
+4579976170
Email
jesper.ougaard.schoennemann1@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper O Schønnemann, Dr
Organizational Affiliation
Hospital southern Jutland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jesper O. Schønnemann
City
Åbenrå
ZIP/Postal Code
6200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper O Schønnemann, Dr.
Phone
+4579976170
Email
jesper.ougaard.schoennemann1@rsyd.dk

12. IPD Sharing Statement

Learn more about this trial

Preoperative Treatment of Malleolar Fractures

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