Effective Treatment of Posttraumatic and Postoperative Edema

Not Applicable

Completed

• Conditions: Edema
• Interventions: Behavioral: ice gel pack; Device: A-V Impulse compression; Other: Multi-layer compression bandage

• Registration Number: NCT01389089
• Lead Sponsor: Luzerner Kantonsspital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-01
• Study Completion: 2010-01
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	ice gel pack	The Control group received ice gel packs and elevation to reduce edema.
A-V Impulse compression	A-V Impulse compression	An A-V Impulse compression device was used to reduce edema.
Multi-layer compression bandage	Multi-layer compression bandage	A multi-layer compression bandage was applied to the lower limb and foot of the patient to reduce edema. Additionally, the limb was constantly elevated.

Primary Outcome Measures

Name	Time	Method
Ankle edema as measured with the figure-of-eight20 method	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.	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with treatment scores measured on the Visual Analogue Scale	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.	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.
Number of postoperative hospitalization days	Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 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.
Amount of daily intake of medication	Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.	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).
Number of adverse events as a measure of safety in each group	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.	Adverse events were defined as: bacterial infection, implant breakage, secondary dislocations, massive wound complications, thrombosis, embolism.
Patient satisfaction scores on overall outcome measured on the Visual Analogue Scale	12 weeks and 1 year postoperative.	Patients had to record on the VAS on how satisfied they were with the overall outcome.
Pain scores measured on the Visual Analogue Scale (VAS)	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.	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.
Number of days until possible operation	Participants were assessed daily for the duration of preoperative hospital stay, an expected average of 5 days.	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.
Range of motion of the ankle joint and foot.	Participants were assessed daily for the duration of postoperative hospital stay, an expected average of 5 days. Follow-up at 6 weeks postoperative.	Plantar flexion, dorsal flexion, inversion and eversion were assessed with a hydrogoniometer.
Amount of volumetric lower limb edema	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.	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.
Number of complains of discomfort or intolerances considering the intervention	Participants were assessed daily for the duration of hospital stay, an expected average of 5 days preoperative and 5 days postoperative.	Every day the patients were asked by the physiotherapist if they had any sort of complains considering the assigned treatment (discomfort or intolerances).
Lower limb function (Foot and ankle ability measure)	12 weeks postoperative, 1 year postoperative.	Questionnaire, self-assessed by the patient. To assess function and participation.
General Health (SF-36)	12 weeks postoperative,1 year postoperative.	Generic assessment of the health status with the SF-36.

Trial Locations

Locations (1)

Luzerner Kantonsspital, Unfallchirurgie; 🇨🇭 Luzern, Switzerland