Efficacy of Leg Casts With Heel Off-loaded in Children

Istituto Ortopedico Rizzoli57 enrolled

Overview

Assess whether by placing a "custom made" splint with heel in the immediate postoperative period until removal of the cast, the rate of pain, the number of healthcare interventions to maintain the off-loaded heel position and number of pressure sores in children wearing lower limb plaster casts is reduced.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Orthopedic Disorders

Interventions

custom made splintDEVICE

Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs.

standard off-load plaster castOTHER

To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Treated by operations to the lower limbs which require immediate plaster casts that include the foot * Treated by osteotomy, joint fusion, patella repositioning and fracture fixation * Children with intact skin at the heel Exclusion Criteria: * Caregivers who cannot speak Italian * Those who refuse to give their consent to take part in the study * Patients with lower limb casts that are allowed to load the limb

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Bologna, Italy

Outcomes

Primary Outcomes

Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group

All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain

Time frame: up to the first 2 days during hospitalization and at cast removal (maximum 30 days).

Secondary Outcomes

Numbers of Participants With Heel Pressure Sores Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.

Time frame: one time at cast removal (expected average of 30 days).

Health Staff/Caregiver Interventions

daily number of interventions by health staff /caregiver to maintain the cast in an off-loaded position, marked on a form given daily to the family/caregiver

Time frame: up to the first 2 days during hospitalization

Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10

The scales had values from 0 to 10 where zero represented no comfort perceived and 10 the best comfort perceived

Time frame: one time at cast removal (expected average of 30 days).

Data from ClinicalTrials.gov

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