Effective Treatment of Posttraumatic and Postoperative Edema

Edema Clinical Trial

Official title:

Effective Treatment of Posttraumatic and Postoperative Edema in Patients With Ankle- and Hindfoot Fractures. A Randomized Controlled Trial Comparing Multi-layer Compression Therapy and A-V Impulse Compression to the Standard Treatment With Ice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389089
• Other study ID #: 616
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: January 2010

Study information

• Verified date: October 2023
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Edema control after ankle- and hindfoot fractures is important. Multi-layer compression bandages or A-V Impulse compression may are more effective in reducing edema than ice.

Description:

After ankle- and hindfoot fractures, edema has a major impact on the time point of surgical intervention and may increases the risk of wound complications and infection postoperatively. Effective treatment of edema, therefore, is of great importance. The aim of this study was to evaluate the efficacy of the multi-layer compression therapy and of the A-V Impulse compression (AVI) in reducing ankle- and hindfoot edema as compared to the standard treatment with ice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Age 18-65 years

• Inpatients

• Acute ankle- or hindfoot fractures (malleolar-, calcaneus-, talus-, and pilon- tibial fractures) including fractures temporary stabilized with an external fixator)

• No walking aids before trauma

• Written informed consent

• Monotrauma

• Preoperative and/or postoperative edema

• Preoperative inclusion

• if delay of surgery due to ankle edema

• if fracture stable enough for temporary removal of orthesis

Exclusion criteria:

• Diabetes Mellitus

• Lymphedema

• Peripheral arterial occlusive disease (PAD)

• Decompensated heart failure or renal insufficiency

• Acute bacterial infection

• Severe osteoporosis

• Pathological fractures

• Known tumors

• Postthrombotic syndrome

• Thrombosis

• Open fractures

• Polytrauma, cerebral trauma

• Neurological deficiencies

• Diuretics

• Pregnancy

• Alcohol or drug abuse

• Psychological disorders

Related Conditions & MeSH terms

• Edema

Intervention

Behavioral:
• ice gel pack
ice gel pack combined with elevation

Other:
• Multi-layer compression bandage
Application of a multi-layer compression bandage to the foot and lower limb (two layers of wool followed by several layers of a short stretch bandage).

Device:
• A-V Impulse compression
A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital, Unfallchirurgie	Luzern

Sponsors (3)

Lead Sponsor	Collaborator
Luzerner Kantonsspital	Medtronic - MITG, Orthofix Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle edema as measured with the figure-of-eight20 method	The figure-of-eight20 is a validated method to measure ankle edema with a simple spring tape. The spring tape follows a figure of eight around the ankle joint.	Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
Secondary	Pain scores measured on the Visual Analogue Scale (VAS)	Visual Analogue Scales were used to assess a daily pain score reflecting strongest and average pain perceived during the previous 24 hours, night pain and pain frequency.	Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-ups at 6 weeks, 12 weeks and 1 year postoperative.
Secondary	Patient satisfaction with treatment scores measured on the Visual Analogue Scale	Visual Analogue Scales were used to assess patient satisfaction with the assigned treatment. The patients had to record their satisfaction with the treatment before surgery and after surgery.	Participants were assessed for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative --> assessment at the day of discharge.
Secondary	Number of days until possible operation	The surgeon daily had to assess whether the patient was ready for operation or not. The wrinkling test served as a criteria for decision making. Accordingly the number of days until possible operation was recorded.	Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days.
Secondary	Number of postoperative hospitalization days	Postoperatively the physiotherapist each day had to record whether or not the patient was ready for discharge. Discharge criteria: 1. patient is able to walk 20 meters and one flight of stairs with crutches. 2. the wound is dry and not irritated. Accordingly, the number of days of postoperative hospitalization until discharge criteria were reached was recorded.	Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days.
Secondary	Range of motion of the ankle joint and foot.	Plantar flexion, dorsal flexion, inversion and eversion were assessed with a hydrogoniometer.	Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative.
Secondary	Amount of daily intake of medication	The intake of daily pain medication was recorded for the instay period (Dafalgan, Novalgin, opiates). Furthermore, the patient file was screened for any Nonsteroidal anti-inflammatory drugs (not allowed).	Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.
Secondary	Number of adverse events as a measure of safety in each group	Adverse events were defined as: bacterial infection, implant breakage, secondary dislocations, massive wound complications, thrombosis, embolism.	Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Patient file was screened for adverse events until 1 year postoperatively.
Secondary	Lower limb function (Foot and ankle ability measure)	Questionnaire, self-assessed by the patient. To assess function and participation.	12 weeks postoperative, 1 year postoperative.
Secondary	General Health (SF-36)	Generic assessment of the health status with the SF-36.	12 weeks postoperative,1 year postoperative.
Secondary	Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale	Patients had to record on the VAS on how satisfied they were with the overall outcome.	12 weeks and 1 year postoperative.
Secondary	Amount of volumetric lower limb edema	Measurements of circumference of the lower limb were used to calculate lower limb volume. The circumferences of the lower limb were measured in increments of 4 cm from ankle level until below the knee joint.	Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative. Follow-up at 6 weeks postoperative.
Secondary	Number of complains of discomfort or intolerances considering the intervention	Every day the patients were asked by the physiotherapist if they had any sort of complains considering the assigned treatment (discomfort or intolerances).	Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.