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Completed

NCT Number: NCT02096562

Knee Swelling Under Use of Compression Stockings After Outpatient Surgery

Outpatients who undergo knee surgery are designated two different clinical study groups. Group A receives common wrapping after surgery to the first postsurgical day and will be provided with compression stockings for the following 10 days, while group B only receives common wrapping and will not be provided with compression stockings.

The investigators are going to investigate the effect of compression stockings on postsurgical swelling and formation of edema on outpatients.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock

Rostock, Meckenburg-Vorpommern, 18057, Germany

About this study

The investigators are planing on investigate the effect of compression stockings on postsurgical swelling and formation of edema. For this purpose the investigators devide outpatients who have undergone knee surgery to two different clinical study groups. Group A receives a common compression bandage after surgery to the first postsurgical day and receives compression stockings afterwards for the following 10 days, while Group B only receives a common compression bandage to the first postsurgical day. Group A will be instructed to wear compression stockings for 24 hours on the first two postsurgical day, afterwards at least for 8 hours a day.

Preoperatively the investigators are going to determine the volume and circumference of both legs using the Bodytronic 600 by Bauerfeind. Subsequently the measurement will be repeated on the first, forth and tenth postsurgical day. The investigators are going to measure the range of motion, also the patients of both groups will be asked to mark pain and tension on a visual analog scale and write down the amount of time they have been lying, sitting and standing each day. Group A will document the amount of time for how long they were wearing compression stockings each day.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • signed release form

Exclusion criteria

  • deep vein thrombosis
  • swelling caused by cardiac, venous or endocrine genesis
  • dysfunction of the lymphatic system
  • dysfunction of kidney or liver
  • Use of water withholding medication
  • massive adiposity
  • cachexia
  • epilepsy

Treatment and study plan

Patients use compression stockings for 10 days after surgery

Other

patients wear compression stocking for 24 hours in the first 2 days after surgery and for at least 8 hours at day 3-10 after surgery

normal therapy - no compression stockings

Other

the patients receive the common therapy according to S2 guidelines

Primary outcomes

  1. Amount of Swelling of lower Extremity (circumference in mm and volume in ml)

    Time frame: 10 days

Secondary outcomes

  1. Pain (visual analoge scale) and Range of Movement (degree of flexion)

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

Prospective Randomized Assessment of Postsurgical Swelling Applying Compression Stockings vs. Conventional Wrapping After Outpatient Surgery

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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