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

NCT03220451 | Completed

• 1 other identifier: CE-17083
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer; Spinal Cord Injuries

Keywords

pressure ulcer; pressure sore; decubitus ulcer; spinal cord injury; adhesive elastic bandage; taping; kinesio taping; neuro taping

Outcome Measures

Primary Outcomes (4)

• Onset of possible adverse events due to the taping treatment

  Visual daily monitoring of possible adverse events, due to the adhesive elastic taping treatment

  Every day, during the 4-week tape application period

• Onset of possible adverse events due to the adhesive elastic taping treatment

  Visual daily monitoring of possible adverse events, due to the adhesive elastic taping treatment

  Every day, during the 4-week follow-up after the tape application period

• Onset of possible events hindering the healing of the pressure ulcer under investigation, due to the taping treatment

  Visual daily monitoring of possible events hindering the healing of the pressure ulcer under investigation, due to the adhesive elastic taping treatment

  Every day (during the 4-week tape application period)

• Onset of possible events hindering the healing of the pressure ulcer under investigation, due to the taping treatment

  Visual daily monitoring of possible events hindering the healing of the pressure ulcer under investigation, due to the adhesive elastic taping treatment

  Every day (during the 4-week follow-up after the tape application period)

Secondary Outcomes (16)

• Evolution of the characteristics of the pressure ulcer under investigation

  Baseline (initial visit); once a week during the whole study period (12 weeks)

• Evolution of the characteristics of the pressure ulcer under investigation

  Baseline (initial visit); week 4; week 8; week 12

• Patient's weight

  Baseline (initial visit)

• Patient's height

  Baseline (initial visit)

• Patient's Body Mass Index (BMI)

  Baseline (initial visit)

Study Arms (1)

Adhesive elastic taping

EXPERIMENTAL

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

Interventions

Adhesive elastic taping PROCEDURE

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

Adhesive elastic taping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montecatone Rehabilitation Institute S.p.A.: lead

Study Sites (1)

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, 40026, Italy

Location

MeSH Terms

Conditions

Pressure Ulcer; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Rita Capirossi, MD Spinal U

  Montecatone Rehabilitation Institute S.p.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 18, 2017
• Study Start: September 25, 2017
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

IT (1)