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Trial record 18 of 55 for:    Recruiting, Not yet recruiting, Available Studies | "Pressure Ulcer"

Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients

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ClinicalTrials.gov Identifier: NCT03220451
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Montecatone Rehabilitation Institute S.p.A.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pressure Ulcer Spinal Cord Injuries Procedure: Adhesive elastic taping Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adhesive elastic taping
After a 4-week observation of the pressure ulcer under investigation, adhesive elastic tape is applied around it for a 4-week period (the tape is changed twice a week), according to a planned application protocol. The ulcer is then observed for a subsequent follow-up period of 4 weeks.
Procedure: Adhesive elastic taping
Adhesive elastic taping placed around a pressure ulcer, according to a planned placement technique




Primary Outcome Measures :
  1. Onset of possible adverse events due to the taping treatment [ Time Frame: Every day, during the 4-week tape application period ]
    Visual daily monitoring of possible adverse events, due to the adhesive elastic taping treatment

  2. Onset of possible adverse events due to the adhesive elastic taping treatment [ Time Frame: 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

  3. Onset of possible events hindering the healing of the pressure ulcer under investigation, due to the taping treatment [ Time Frame: Every day (during the 4-week 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

  4. Onset of possible events hindering the healing of the pressure ulcer under investigation, due to the taping treatment [ Time Frame: 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


Secondary Outcome Measures :
  1. Evolution of the characteristics of the pressure ulcer under investigation [ Time Frame: Baseline (initial visit); once a week during the whole study period (12 weeks) ]
    Pressure ulcer assessment with Bates-Jensen Wound Assessment Tool (BWAT), once a week

  2. Evolution of the characteristics of the pressure ulcer under investigation [ Time Frame: Baseline (initial visit); week 4; week 8; week 12 ]
    Photographic shot of the pressure ulcer

  3. Patient's weight [ Time Frame: Baseline (initial visit) ]
    Patient's weight, in kilograms (kg)

  4. Patient's height [ Time Frame: Baseline (initial visit) ]
    Patient's height, in meters (m)

  5. Patient's Body Mass Index (BMI) [ Time Frame: Baseline (initial visit) ]
    Patient's BMI assessment (as one of the nutritional status indicators): Patient's weight and Patient's height are combined as kg/m^2

  6. Change in patient's blood hemoglobin [ Time Frame: Baseline (initial visit); week 4; week 8; week 12 ]
    Dosage of blood hemoglobin (as one of the nutritional status indicators): grams per deciliter

  7. Change in patient's blood number of lymphocytes: [ Time Frame: Baseline (initial visit); week 4; week 8; week 12 ]
    Dosage of blood number of lymphocytes (as one of the nutritional status indicators): billions per liter

  8. Change in patient's blood albumin [ Time Frame: Baseline (initial visit); week 4; week 8; week 12 ]
    Dosage of blood albumin (as one of the nutritional status indicators): grams per deciliter

  9. Change in patient's blood prealbumin [ Time Frame: Baseline (initial visit); week 4; week 8; week 12 ]
    Dosage of blood prealbumin (as one of the nutritional status indicators): milligrams per deciliter

  10. Change in patient's blood total proteins [ Time Frame: Baseline (initial visit); week 4; week 8; week 12 ]
    Dosage of blood total proteins (as one of the nutritional status indicators): grams per deciliter

  11. Change in patient's blood transferrin [ Time Frame: Baseline (initial visit); week 4; week 8; week 12 ]
    Dosage of blood total transferrin (as one of the nutritional status indicators): milligrams per deciliter

  12. Onset of patient's pain [ Time Frame: Baseline (initial visit); twice a day, during the whole study period (12 weeks) ]
    Pain assessment with Numeric Rating Scale (NRS), twice a day (morning and evening) during the whole study period (12 weeks)

  13. Site of patient's pain (if any) [ Time Frame: Baseline (initial visit); twice a day, during the whole study period (12 weeks) ]
    Description of the site of possibly observed pain, twice a day (morning and evening) during the whole study period (12 weeks)

  14. Change of patient's spasticity [ Time Frame: Baseline (initial visit); week 2; week 4; week 6; week 8; week 10; week 12 ]
    Spasticity assessment with the Modified Ashworth Scale (MAS)

  15. Tape employed for taping treatment [ Time Frame: End of tape application period (week 8) ]
    Quantification of total tape employed for the taping application treatment for each pressure ulcer (in meters)

  16. Time-operator employed for taping treatment [ Time Frame: End of tape application period (week 8) ]
    Quantification of total time-operator employed for the taping application treatment for each pressure ulcer (in minutes)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220451


Contacts
Contact: Rita Capirossi, MD Spinal U +39 0542 632811 rita.capirossi@montecatone.com

Locations
Italy
Montecatone Rehabilitation Institute S.p.A. Recruiting
Imola, BO, Italy, 40026
Contact: Rita Capirossi, MD Spinal U    +39 0542 632811    rita.capirossi@montecatone.com   
Sub-Investigator: Paola Paglierani, FT         
Sub-Investigator: Debora Donatini, Nurse         
Sponsors and Collaborators
Montecatone Rehabilitation Institute S.p.A.
Investigators
Principal Investigator: Rita Capirossi, MD Spinal U Montecatone Rehabilitation Institute S.p.A.

Responsible Party: Montecatone Rehabilitation Institute S.p.A.
ClinicalTrials.gov Identifier: NCT03220451     History of Changes
Other Study ID Numbers: CE-17083
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Montecatone Rehabilitation Institute S.p.A.:
pressure ulcer
pressure sore
decubitus ulcer
spinal cord injury
adhesive elastic bandage
taping
kinesio taping
neuro taping

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Spinal Cord Injuries
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Skin Ulcer
Skin Diseases