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

NCT03220451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-01-20

No results posted yet for this study

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.

Conditions

  • Pressure Ulcer
  • Spinal Cord Injuries

Interventions

PROCEDURE

Adhesive elastic taping

Adhesive elastic taping placed around a pressure ulcer, according to a planned placement technique

Sponsors & Collaborators

  • Montecatone Rehabilitation Institute S.p.A.

    lead OTHER

Principal Investigators

  • Rita Capirossi, MD Spinal U · Montecatone Rehabilitation Institute S.p.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2020-03-20
Completion
2020-03-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220451 on ClinicalTrials.gov