Efficacy of Ready-Made Tubular Compression Devices
Efficacy of Ready-Made Tubular Compression Devices
Background: Conventional compression therapy of venous leg ulcers consists of applying pressure bandages; this operation is not simple and requires training. A heelless open-toed elastic compression device knitted in tubular form (Tubulcus®, Laboratoires Innothera, Arcueil, France) represents a valuable alternative. It provides graduated compression with a value of 30-40mmHg at the ankle. Appropriate pressure is exerted regardless of the skill of the fitter (who may even be the patient), and fitting of the device is facilitated by the use of a specific positioner. The aim of this trial was to compare the efficacy and tolerability of the new compression device and a short-stretch compression bandage (Rosidal® K, Lohmann & Rauscher International GmbH & Co. KG, Rengsdorf, Germany) for 12 weeks in patients with venous leg ulcers.
Materials and Methods: This was an open, randomized, comparative, international multicenter trial in two parallel groups in France, Germany, Austria, and Switzerland. Study patients had venous ulcers for less than three months, and ulcers measured no more than 5cm in diameter. Ulcer area was assessed by a physician by means of computerized planimetry each week or on premature discontinuation of treatment. The per-protocol (PP) population comprised 88 patients treated with the tubular device (50 in France/Switzerland, 38 in Germany/Austria) and 90 treated with bandages (52 in France/Switzerland, 38 in Germany/Austria).
Results: Complete healing was observed in 58 percent of patients in the tubular compression device group and in 56.7 percent in the bandage group. The difference between the two treatment groups was -1.3 percent, and the 90-percent confidence interval (-13.5%-10.9%) was within the limits of noninferiority specified in the protocol, i.e., =15%. These results show that the efficacy of the tubular device was not inferior to that of bandages and that neither treatment was superior in efficacy to the other. The surface area of ulcers not completely healed within 12 weeks was reduced in 67.6 percent of patients treated with the tubular device and in 59 percent of those treated with bandaging. The median healing time was 42 days (in patients with complete healing), with no difference between the two treatment groups (p =0.80).
Conclusion: The results of this trial demonstrate the noninferiority of efficacy of a new type of tubular compression device compared with short-stretch bandages. The good healing rates, particularly with bandages, was doubtless assisted by the very high rate of compliance and the fact that bandaging was performed only by experienced medical staff.
Venous leg ulcers are skin disorders of the lower leg that do not heal spontaneously caused by chronic venous insufficiency. They affect at least 0.2 percent of the population in the developed world, and their prevalence increases considerably with age, affecting about two percent of the population over the age of 80. Treatment of venous ulcers aims to ensure healing of the wound and prevention of recurrence. Compression, either alone or combined with surgery, is considered the principal treatment for venous ulcers and takes priority over local wound treatment. Today, short- and long-stretch bandages constitute the forms of treatment most commonly used in everyday practice. These bandages are changed every two or three days by medical staff but also by patients themselves or family members. In the latter case, the bandages are often poorly positioned; they may be either too loose, causing slippage, or they may be too tight, causing constriction. This results in impairment of patients' quality of life, poor compliance, and consequently, delayed healing. A new heelless, open-toed tubular elastic compression device (Tubulcus®, Laboratoires Innothera, Arcueil, France) exerts a clearly defined pressure that remains constant over time. It can be applied without the need for a qualified fitter, and application is facilitated by a specific positioner.
The purpose of this study was to compare the efficacy and safety of the new tubular compression device with a short-stretch compression bandage for 12 weeks in patients with venous leg ulcers.
The new ready-made knee-length tubular compression device for the treatment of venous ulcers exerts graduated pressure with the highest compression (30-40mmHg) at the ankle, diminishing up the calf, and corresponds, in concern of exerted pressure, to class III compression stockings. It is open toed and has no heel, which permits more flexible placement of the maximal pressure, as opposed to stockings with heels. Due to the fact that it is a tubular, knitted, ready-made device, the appropriate pressure is exerted regardless of fitter's skill. This is in contrast to the application of the correct pressure with bandages, which is possible, especially with bandage systems, but is not easy, and training is required. The test device is composed of 34 percent elastan, 27 percent polyamide, and 27 percent cotton at the inside (it does not contain latex). The device can be reused and laundered at 60° C.
The compression bandage (Rosidal® K, Lohmann & Rauscher International GmbH & Co. KG, Rengsdorf, Germany) is made from 100-percent cotton and has short-stretch properties (about 90%).
Background: Conventional compression therapy of venous leg ulcers consists of applying pressure bandages; this operation is not simple and requires training. A heelless open-toed elastic compression device knitted in tubular form (Tubulcus®, Laboratoires Innothera, Arcueil, France) represents a valuable alternative. It provides graduated compression with a value of 30-40mmHg at the ankle. Appropriate pressure is exerted regardless of the skill of the fitter (who may even be the patient), and fitting of the device is facilitated by the use of a specific positioner. The aim of this trial was to compare the efficacy and tolerability of the new compression device and a short-stretch compression bandage (Rosidal® K, Lohmann & Rauscher International GmbH & Co. KG, Rengsdorf, Germany) for 12 weeks in patients with venous leg ulcers.
Materials and Methods: This was an open, randomized, comparative, international multicenter trial in two parallel groups in France, Germany, Austria, and Switzerland. Study patients had venous ulcers for less than three months, and ulcers measured no more than 5cm in diameter. Ulcer area was assessed by a physician by means of computerized planimetry each week or on premature discontinuation of treatment. The per-protocol (PP) population comprised 88 patients treated with the tubular device (50 in France/Switzerland, 38 in Germany/Austria) and 90 treated with bandages (52 in France/Switzerland, 38 in Germany/Austria).
Results: Complete healing was observed in 58 percent of patients in the tubular compression device group and in 56.7 percent in the bandage group. The difference between the two treatment groups was -1.3 percent, and the 90-percent confidence interval (-13.5%-10.9%) was within the limits of noninferiority specified in the protocol, i.e., =15%. These results show that the efficacy of the tubular device was not inferior to that of bandages and that neither treatment was superior in efficacy to the other. The surface area of ulcers not completely healed within 12 weeks was reduced in 67.6 percent of patients treated with the tubular device and in 59 percent of those treated with bandaging. The median healing time was 42 days (in patients with complete healing), with no difference between the two treatment groups (p =0.80).
Conclusion: The results of this trial demonstrate the noninferiority of efficacy of a new type of tubular compression device compared with short-stretch bandages. The good healing rates, particularly with bandages, was doubtless assisted by the very high rate of compliance and the fact that bandaging was performed only by experienced medical staff.
Venous leg ulcers are skin disorders of the lower leg that do not heal spontaneously caused by chronic venous insufficiency. They affect at least 0.2 percent of the population in the developed world, and their prevalence increases considerably with age, affecting about two percent of the population over the age of 80. Treatment of venous ulcers aims to ensure healing of the wound and prevention of recurrence. Compression, either alone or combined with surgery, is considered the principal treatment for venous ulcers and takes priority over local wound treatment. Today, short- and long-stretch bandages constitute the forms of treatment most commonly used in everyday practice. These bandages are changed every two or three days by medical staff but also by patients themselves or family members. In the latter case, the bandages are often poorly positioned; they may be either too loose, causing slippage, or they may be too tight, causing constriction. This results in impairment of patients' quality of life, poor compliance, and consequently, delayed healing. A new heelless, open-toed tubular elastic compression device (Tubulcus®, Laboratoires Innothera, Arcueil, France) exerts a clearly defined pressure that remains constant over time. It can be applied without the need for a qualified fitter, and application is facilitated by a specific positioner.
The purpose of this study was to compare the efficacy and safety of the new tubular compression device with a short-stretch compression bandage for 12 weeks in patients with venous leg ulcers.
The new ready-made knee-length tubular compression device for the treatment of venous ulcers exerts graduated pressure with the highest compression (30-40mmHg) at the ankle, diminishing up the calf, and corresponds, in concern of exerted pressure, to class III compression stockings. It is open toed and has no heel, which permits more flexible placement of the maximal pressure, as opposed to stockings with heels. Due to the fact that it is a tubular, knitted, ready-made device, the appropriate pressure is exerted regardless of fitter's skill. This is in contrast to the application of the correct pressure with bandages, which is possible, especially with bandage systems, but is not easy, and training is required. The test device is composed of 34 percent elastan, 27 percent polyamide, and 27 percent cotton at the inside (it does not contain latex). The device can be reused and laundered at 60° C.
The compression bandage (Rosidal® K, Lohmann & Rauscher International GmbH & Co. KG, Rengsdorf, Germany) is made from 100-percent cotton and has short-stretch properties (about 90%).
