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The post-operative treatment of pediatric patients operated for the correction of flat foot, sees today the use of preformed leg-foot splint (Walker) as an alternative to the application of plaster casts. The change of the immobilization system has led to the appearance of problems of tolerability in particular in the skin. The aim of the study is to assess whether by placing a polyurethane foam dress at the heel in the immediate postoperative period until removal of the Walker, the rate of skin lesion and pain is reduced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyurethane foam | Experimental |
| |
| standard care | No Intervention | Only application of the Walker in the immediate postoperative period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyurethane foam dress | Device | Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) | Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss. | every day until discharge (expected average of 3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (Score on the "Numeric Rating Scale") | Pain Score on the "Numeric Rating Scale" > 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain. | up to the first 3 days post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caterina Guerra, RN | Istituto Ortopedico Rizzoli | Principal Investigator |
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The study began on May 2014 and ended in May 2015 when the eighties patient was enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Polyurethane Foam | polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker |
| FG001 | Standard Care | Only application of the Walker in the immediate postoperative period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polyurethane Foam | polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker |
| BG001 | Standard Care |
| 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 | Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) | Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss. | Posted | Count of Participants | Participants | every day until discharge (expected average of 3 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 | Polyurethane Foam | polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of the Research Nursing Unit | Istituto Ortopedico Rizzoli | 0516366694 | 0039 | cristiana.forni@ior.it |
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| ID | Term |
|---|---|
| D005413 | Flatfoot |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| type of surgery:Calcaneal Osteotomy | Count of Participants | Participants |
|
| type of analgesia:peripheral nerve blocks analgesia | Count of Participants | Participants |
|
polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker |
| OG001 | Standard Care |
|
|
| Secondary | Pain (Score on the "Numeric Rating Scale") | Pain Score on the "Numeric Rating Scale" > 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain. | Posted | Count of Participants | Participants | up to the first 3 days post intervention |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Standard Care | 0 | 42 | 0 | 42 | 0 | 42 |
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| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |