NCT03220451

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

Completed NA Last updated 20 January 2021

What this trial tests

NA trial testing Adhesive elastic taping in Pressure Ulcer in 24 participants. Completed in 20 March 2020.

Timeline

25 September 2017

Primary endpoint
20 March 2020

20 March 2020

Quick facts

Lead sponsor	Montecatone Rehabilitation Institute S.p.A.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	25 September 2017
Primary completion	20 March 2020
Estimated completion	20 March 2020
Sites	1 location across Italy

Drugs / interventions tested

• Adhesive elastic taping

Conditions studied

• Pressure Ulcer — all drugs for Pressure Ulcer →
• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

Montecatone Rehabilitation Institute S.p.A.

Who can join

18 and older, any sex, with Pressure Ulcer or Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reactive Oxygen Species and Pressure Ulcer Formation after Traumatic Injury to Spinal Cord and Brain.
   Kumar S, Theis T, Tschang M, Nagaraj V, et al · · 2021 · cited 26× · PMID 34202655 · DOI 10.3390/antiox10071013