Clinical trial NCT02096562: Knee Swelling Under Use of Compression Stockings After Outpatient Surgery
Official title: Prospective Randomized Assessment of Postsurgical Swelling Applying Compression Stockings vs. Conventional Wrapping After Outpatient Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain Swelling
Keywords: knee welling outpatient compression stockings
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Amount of Swelling of lower Extremity (circumference in mm and volume in ml)
timeFrame: 10 days
Secondary outcomes:
measure: Pain (visual analoge scale) and Range of Movement (degree of flexion)
timeFrame: 10 days
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
state: Meckenburg-Vorpommern
Study officials:
affiliation: OUK Rostock
name: Thomas Tischer, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Tischer TS, Oye S, Lenz R, Kreuz P, Mittelmeier W, Bader R, Tischer T. Impact of compression stockings on leg swelling after arthroscopy - a prospective randomised pilot study. BMC Musculoskelet Disord. 2019 Apr 9;20(1):161. doi: 10.1186/s12891-019-2540-1.