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OpenTrials
Completed

NCT Number: NCT02468154

Efficacy of Leg Casts With Heel Off-loaded in Children

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.

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Key information

Conditions

Orthopedic Disorders Musculoskeletal Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

custom made splint

Device

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 cast

Other

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

Primary outcomes

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

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

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

Secondary outcomes

  1. 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).

  2. Health Staff/Caregiver Interventions

    Time frame: up to the first 2 days during hospitalization

    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

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

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

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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Efficacy of Leg Casts With Heel Off-loaded in Children: Open Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2015
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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