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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| splint | Experimental | Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded. |
|
| standard care | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to the first 2 days during hospitalization and at cast removal (maximum 30 days). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luisa Veronesi, RN | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | Bologna | 40136 | Italy |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | up to the first 2 days during hospitalization and at cast removal (maximum 30 days). |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luisa Veronesi | Istituto Ortopedico Rizzoli | 0516366694 | 0039 | cristiana.forni@ior.it |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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|
| 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 |
|
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
| 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 | one time at cast removal (expected average of 30 days). |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| bone surgical intervention (vs soft tissue surgical intervention) | Number | participants |
|
| spica cast | Number | participants |
|
| over the knee cast | Number | participants |
|
| under the knee cast | Number | participants |
|
| pain killer (opioid) | Number | participants |
|
| 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 |
|
|
| 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. | Posted | Number | participants | one time at cast removal (expected average of 30 days). |
|
|
|
| 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 | Posted | Mean | Standard Deviation | daily number of interventions | up to the first 2 days during hospitalization |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | one time at cast removal (expected average of 30 days). |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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 | 0 | 28 | 0 | 28 |
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