Multicenter randomized trial comparing compression with elastic stocking versus bandage after surgery for varicose veins

Fabrizio Mariani, Enrico Maria Marone, Vincenzo Gasbarro, Matteo Bucalossi, Sara Spelta, Felix Amsler, Michele Agnati, Roberto Chiesa

Research output: Contribution to journalArticle

Abstract

Objectives Postoperative limb compression is widely used after venous surgery to prevent thromboembolism and to reduce hemorrhage, edema, hematoma, and pain. Only limited studies have been published regarding the most adequate postoperative compression therapy after varicose vein surgery. This study evaluated the effectiveness of a new stocking kit used for postoperative limb compression. Methods The study compared the clinical practicability, ease to use, effectiveness, and safety of a postoperative stocking system (23 to 32 mmHg at the ankle) with compression bandages (control group). This prospective, randomized, open-label clinical trial, was performed in three Italian centers specializing in venous surgery. Sixty consecutive patients (classification CEAP C 2,S) underwent unilateral varicose vein surgery at one of the three centers. After surgery, patients were randomized for postoperative compression therapy with a new stocking system (Sigvaris Postoperative Kit; Ganzoni Sigvaris Corp, Winterthur, Switzerland) or standard stretch bandages (30 patients per group). Primary end points were incidence of venous thromboembolism, hemorrhage, limb hematoma, or edema. Results No episodes of venous thromboembolism were observed. The mean area of thigh hematoma on postoperative days 7 and 14 was 75.70 cm 2 and 2.93 cm 2, respectively, for the stocking group, and 92.97 cm 2 and 5.42 cm 2 for the bandage group (not significant). On postoperative day 7, edema was found in 50% of the patients wearing bandages and in 20% of the patients wearing the stocking kit, which was a significant reduction. No statistical difference was recorded for postoperative pain; however, better patient acceptance and quality of life after the operation were recorded in the stocking group. Conclusion Patients can be effectively treated with the Sigvaris Postoperative Kit. Patients treated with stockings have less edema compared with standard bandaging, and the application of the stocking kit improves patient quality of life and compliance with postoperative compression therapy.

Original languageEnglish
Pages (from-to)115-122
Number of pages8
JournalJournal of Vascular Surgery
Volume53
Issue number1
DOIs
Publication statusPublished - Jan 2011

Fingerprint

Compression Stockings
Varicose Veins
Bandages
Multicenter Studies
Edema
Hematoma
Extremities
Venous Thromboembolism
Compression Bandages
Quality of Life
Hemorrhage
Thromboembolism
Postoperative Pain
Thigh
Switzerland
Ankle
Therapeutics
Clinical Trials
Safety
Pain

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

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Multicenter randomized trial comparing compression with elastic stocking versus bandage after surgery for varicose veins. / Mariani, Fabrizio; Marone, Enrico Maria; Gasbarro, Vincenzo; Bucalossi, Matteo; Spelta, Sara; Amsler, Felix; Agnati, Michele; Chiesa, Roberto.

In: Journal of Vascular Surgery, Vol. 53, No. 1, 01.2011, p. 115-122.

Research output: Contribution to journalArticle

Mariani, Fabrizio ; Marone, Enrico Maria ; Gasbarro, Vincenzo ; Bucalossi, Matteo ; Spelta, Sara ; Amsler, Felix ; Agnati, Michele ; Chiesa, Roberto. / Multicenter randomized trial comparing compression with elastic stocking versus bandage after surgery for varicose veins. In: Journal of Vascular Surgery. 2011 ; Vol. 53, No. 1. pp. 115-122.
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abstract = "Objectives Postoperative limb compression is widely used after venous surgery to prevent thromboembolism and to reduce hemorrhage, edema, hematoma, and pain. Only limited studies have been published regarding the most adequate postoperative compression therapy after varicose vein surgery. This study evaluated the effectiveness of a new stocking kit used for postoperative limb compression. Methods The study compared the clinical practicability, ease to use, effectiveness, and safety of a postoperative stocking system (23 to 32 mmHg at the ankle) with compression bandages (control group). This prospective, randomized, open-label clinical trial, was performed in three Italian centers specializing in venous surgery. Sixty consecutive patients (classification CEAP C 2,S) underwent unilateral varicose vein surgery at one of the three centers. After surgery, patients were randomized for postoperative compression therapy with a new stocking system (Sigvaris Postoperative Kit; Ganzoni Sigvaris Corp, Winterthur, Switzerland) or standard stretch bandages (30 patients per group). Primary end points were incidence of venous thromboembolism, hemorrhage, limb hematoma, or edema. Results No episodes of venous thromboembolism were observed. The mean area of thigh hematoma on postoperative days 7 and 14 was 75.70 cm 2 and 2.93 cm 2, respectively, for the stocking group, and 92.97 cm 2 and 5.42 cm 2 for the bandage group (not significant). On postoperative day 7, edema was found in 50{\%} of the patients wearing bandages and in 20{\%} of the patients wearing the stocking kit, which was a significant reduction. No statistical difference was recorded for postoperative pain; however, better patient acceptance and quality of life after the operation were recorded in the stocking group. Conclusion Patients can be effectively treated with the Sigvaris Postoperative Kit. Patients treated with stockings have less edema compared with standard bandaging, and the application of the stocking kit improves patient quality of life and compliance with postoperative compression therapy.",
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