Pilot Study on the Use of Adhesive Elastic Taping as "add-on" Treatment for the Therapy of Medium/Severe Grade Pressure Ulcers in Spinal Cord Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Onset of possible adverse events due to the taping treatment
研究概览
简要总结
All patients with a significant deficiency of skin sensitivity and reduced mobility are potentially at risk of Pressure Ulcers (PUs), in particular the persons affected by Spinal Cord Injury (SCI), also due to their frequent alteration or loss of subcutaneous skin sensitivity. Pressure sores are one of the most common and fearful complications in SCI, with a severe impact on quality of life and on care health costs. They are often the cause of lengthening the time of hospitalization, slowing down clinical and rehabilitation programs and re-hospitalization.
PUs, when arisen, heal slowly and, despite the protracted conservative medical therapies, sometimes they do not come to complete healing. Sometimes plastic surgery is needed, although even after it recurrence rates remain high.
Further treatments have been proposed in addition to the usual medication, however they are characterized by a certain degree of invasiveness and are often conditioned by the availability of specific and sometimes expensive equipment, as well as by the presence of highly qualified personnel. In general, there is also a lack of good quality clinical trials for assessing their effectiveness and safety and they are often not decisive, especially for severe and recalcitrant ulcers.
Among alternative techniques for the healing of skin ulcers in general, the adhesive elastic bandage, also known as "kinesio taping" and already recognized for the treatment of edema, hematoma and scarring, has been proposed. However, specific protocols and published studies are not available for PUs.
The Montecatone Rehabilitation Institute, that hosts the largest Spinal Unit in Italy, pays great attention to the prevention and treatment of PUs in both acute and chronic patients. The rationale for the taping positioning around PUs investigated in this study is to improve lymphatic drainage and reactivation of the superficial bloodstream by increasing interstitial spaces and reducing skin and subcutaneous compression, notoriously compromised in the areas of onset of pressure sores. The total shortage in the literature and in user manuals of taping protocols for PUs supports this preliminary, exploratory, descriptive and uncontrolled pilot study with the primary aim of verifying the safety of a taping treatment for medium/severe grade PUs, "add-on" to the usual care. The choice of the ulcer sites selected (sacral and heel) has been affected by the feasibility of tape positioning.
详细描述
All patients with a significant deficiency of skin sensitivity and reduced mobility are potentially at risk of Pressure Ulcers (PUs), in particular the persons affected by Spinal Cord Injury (SCI), also due to their frequent alteration or loss of subcutaneous skin sensitivity. More than one-third of individuals hospitalized in Spinal Units for rehabilitative treatments following a SCI develop PUs during acute hospitalization and it was also estimated that up to 85% of SCI persons develop at least one PU in the course of their lives. Pressure sores are therefore one of the most common and fearful complications in SCI, with a severe impact on quality of life and on care health costs. They are often the cause of lengthening the time of hospitalization, slowing down clinical and rehabilitation programs and re-hospitalization.
PUs, when arisen, heal slowly and, despite the protracted conservative medical therapies, sometimes they do not come to complete healing. Sometimes plastic surgery is needed, although even after it recurrence rates remain high.
Traditional treatment of PUs consists in the use of advanced dressings that may vary depending on the degree of staging of the lesion, its extent and the presence of clinical signs of necrosis and/or deep soft tissue infection. In addition to dressings, treatment cycles with intermittent negative pressure therapy can be indicated and the surgical approach (toilets + plastic reconstruction) could be reserved to chronic lesions with no response to traditional dressings or in the case of underlying osteomyelitis.
Alternative treatments (e.g. electrotherapy, pulsed electromagnetic fields, ultraviolet light, infrared radiation, laser therapy, ultrasound, shock waves) have been proposed in addition to the usual medication, however they are characterized by a certain degree of invasiveness and are often conditioned by the availability of specific and sometimes expensive equipment, as well as by the presence of highly qualified personnel. In general, there is also a lack of good quality clinical trials for assessing the effectiveness and safety of such techniques that are often not decisive for healing, especially for severe and recalcitrant lesions.
Among alternative techniques for the healing of skin ulcers in general, the adhesive elastic bandage, also known as "kinesio taping" or "neuro taping" and already recognized for the treatment of edema, hematoma and scarring, has been proposed. However, specific protocols and published studies are not available for PUs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury of any aetiology (traumatic and non-traumatic) and any neurological level, both complete and incomplete, occurred at least 3 months before;
- •Pressure ulcer occurred at least 1 month before;
- •Pressure ulcer staged III or IV, according to the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel (NPUAP/EPUAP) classification;
- •Pressure ulcer located in sacral or heel region;
- •Pressure ulcer with cleansed bottom;
- •Stable clinical conditions;
- •Cognitive integrity and full collaboration of the subject.
排除标准
- •Ulcerative skin lesion not due to pressure;
- •Pressure ulcer with frank signs of infection or suggestive of underlying osteomyelitis;
- •Eczema and/or irritated and/or psoriatic skin around the pressure ulcer;
- •Ongoing deep venous thrombosis;
- •Known allergy to elastic adhesive tape;
- •Ongoing neoplasia;
- •Uncompensated diabetes with signs of peripheral vasculopathy;
- •Evidence of peripheral polyneuropathy;
- •Circulatory problems (e.g. severe lower limb artery disease);
- •Significant respiratory problems (e.g. with ongoing assisted ventilation);
- •Ongoing sepsis;
- •Ongoing severe clinical instability;
- •Ongoing oral anticoagulant therapy;
- •Ongoing pregnancy.
结局指标
主要结局
Onset of possible adverse events due to the taping treatment
时间窗: Every day, during the 4-week tape application period
Visual daily monitoring of possible adverse events, due to the adhesive elastic taping treatment
Onset of possible events hindering the healing of the pressure ulcer under investigation, due to the taping treatment
时间窗: Every day (during the 4-week follow-up after the tape application period)
Visual daily monitoring of possible events hindering the healing of the pressure ulcer under investigation, due to the adhesive elastic taping treatment
Onset of possible adverse events due to the adhesive elastic taping treatment
时间窗: Every day, during the 4-week follow-up after the tape application period
Visual daily monitoring of possible adverse events, due to the adhesive elastic taping treatment
次要结局
- Change in patient's blood hemoglobin(Baseline (initial visit); week 4; week 8; week 12)
- Change in patient's blood total proteins(Baseline (initial visit); week 4; week 8; week 12)
- Patient's weight(Baseline (initial visit))
- Patient's height(Baseline (initial visit))
- Tape employed for taping treatment(End of tape application period (week 8))
- Change in patient's blood prealbumin(Baseline (initial visit); week 4; week 8; week 12)
- Change in patient's blood transferrin(Baseline (initial visit); week 4; week 8; week 12)
- Change of patient's spasticity(Baseline (initial visit); week 2; week 4; week 6; week 8; week 10; week 12)
- Time-operator employed for taping treatment(End of tape application period (week 8))
- Evolution of the characteristics of the pressure ulcer under investigation(Baseline (initial visit); week 4; week 8; week 12)
- Patient's Body Mass Index (BMI)(Baseline (initial visit))
- Change in patient's blood number of lymphocytes:(Baseline (initial visit); week 4; week 8; week 12)
- Change in patient's blood albumin(Baseline (initial visit); week 4; week 8; week 12)
- Onset of patient's pain(Baseline (initial visit); twice a day, during the whole study period (12 weeks))
- Site of patient's pain (if any)(Baseline (initial visit); twice a day, during the whole study period (12 weeks))