Orthopedic Disorders
Conditions
Brief summary
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.
Interventions
DEVICEcustom made splint
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.
OTHERstandard off-load plaster cast
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
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score on the Numeric Rating Scale or Visual Rating Scale or Face, Legs Activity Cry Consolability According to Age Group | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | one time at cast removal (expected average of 30 days). | — |
| Health Staff/Caregiver Interventions | 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 |
| Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10 | 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 |
Countries
Italy
Participant flow
Recruitment details
Between November 2014-August 2015, 57 paediatric orthopaedic patients who need a lower limb plaster cast after surgery out of the 172 potentially eligible (33.1%) were enrolled in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Splint Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
custom made splint: 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. | 29 |
| Standard Care 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
standard off-load plaster cast: 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 | 28 |
| Total | 57 |
Baseline characteristics
| Characteristic | Splint | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 10.4 years STANDARD_DEVIATION 3.96 | 10.5 years STANDARD_DEVIATION 3.72 | 10.5 years STANDARD_DEVIATION 3.84 |
| bone surgical intervention (vs soft tissue surgical intervention) | 22 participants | 21 participants | 43 participants |
| over the knee cast | 11 participants | 16 participants | 27 participants |
| pain killer (opioid) | 4 participants | 4 participants | 8 participants |
| Region of Enrollment Italy | 29 participants | 28 participants | 57 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
| spica cast | 9 participants | 4 participants | 13 participants |
| under the knee cast | 9 participants | 8 participants | 17 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
Primary
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Splint | Pain Score on the Numeric Rating Scale or Visual Rating Scale or Face, Legs Activity Cry Consolability According to Age Group | 4.4 units on a scale | Standard Deviation 2.4 |
| Standard Care | Pain Score on the Numeric Rating Scale or Visual Rating Scale or Face, Legs Activity Cry Consolability According to Age Group | 3.9 units on a scale | Standard Deviation 3 |
Secondary
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Splint | Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10 | 8.9 units on a scale | Standard Deviation 1.1 |
| Standard Care | Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10 | 7.6 units on a scale | Standard Deviation 1.7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Splint | Health Staff/Caregiver Interventions | 2.1 daily number of interventions | Standard Deviation 3.2 |
| Standard Care | Health Staff/Caregiver Interventions | 5.2 daily number of interventions | Standard Deviation 3.6 |
Secondary
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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Splint | 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. | 1 participants |
| Standard Care | 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. | 5 participants |