## Protocol Section
### Identification Module
**NCT ID:** NCT03039179

**Acronym:** SCHIUMABIMB

**Brief Title:** Polyurethane Foam on the Heel for Prevention in Children

**Official Title:** Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 0024520
#### Organization
**Class:** OTHER
**Full Name:** Istituto Ortopedico Rizzoli
### Status Module
#### Completion Date
**Date:** 2015-08-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-02-05

**Type:** ACTUAL

**Last Update Submit Date:** 2020-01-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-07-31

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-03-22

**Type:** ACTUAL

**Results First Submit Date:** 2017-02-01

**Results First Submit QC Date:** 2017-02-01

#### Start Date
**Date:** 2014-07-01

**Type:** ACTUAL

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2017-02-01
**Type:** ESTIMATED
**Study First Submit Date:** 2017-01-31
**Study First Submit QC Date:** 2017-01-31
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istituto Ortopedico Rizzoli

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Flat Foot

- Pressure Ulcer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: polyurethane foam dress

**Label:** Polyurethane foam

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Only application of the Walker in the immediate postoperative period.

**Label:** standard care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Polyurethane foam

**Description:** Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker

**Name:** polyurethane foam dress

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)

**Time Frame:** every day until discharge (expected average of 3 days)

#### Secondary Outcomes

**Description:** 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.

**Measure:** Pain (Score on the "Numeric Rating Scale")

**Time Frame:** up to the first 3 days post intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Children aged \> 3 years underwent surgery for flat foot
* 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 after surgery

**Maximum Age:** 18 Years

**Minimum Age:** 3 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Istituto Ortopedico Rizzoli

**Name:** Caterina Guerra, RN

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012883

- Term: Skin Ulcer

- ID: D000012871

- Term: Skin Diseases

- ID: D000070558

- Term: Talipes

- ID: D000005531

- Term: Foot Deformities, Acquired

- ID: D000005530

- Term: Foot Deformities

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000005532

- Term: Foot Deformities, Congenital

- ID: D000038061

- Term: Lower Extremity Deformities, Congenital

- ID: D000017880

- Term: Limb Deformities, Congenital

- ID: D000009139

- Term: Musculoskeletal Abnormalities

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M6870

- Name: Pressure Ulcer

- Relevance: HIGH

- As Found: Pressure Ulcer

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M8543

- Name: Flatfoot

- Relevance: HIGH

- As Found: Flat Foot

- ID: M15686

- Name: Skin Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6255

- Name: Clubfoot

- Relevance: LOW

- As Found: Unknown

- ID: M586

- Name: Talipes

- Relevance: LOW

- As Found: Unknown

- ID: M8017

- Name: Equinus Deformity

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M8654

- Name: Foot Deformities

- Relevance: LOW

- As Found: Unknown

- ID: M8656

- Name: Foot Deformities, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M8655

- Name: Foot Deformities, Acquired

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M24718

- Name: Lower Extremity Deformities, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M20062

- Name: Limb Deformities, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M12096

- Name: Musculoskeletal Abnormalities

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005413

- Term: Flatfoot

- ID: D000003668

- Term: Pressure Ulcer

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Polyurethane Foam

**Deaths Num At Risk:** 38

**Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker

**ID:** EG000

**Other Num at Risk:** 38

**Serious Number At Risk:** 38

**Title:** Polyurethane Foam

**Group ID:** EG001

**Title:** Standard Care

**Deaths Num At Risk:** 42

**ID:** EG001

**Other Num at Risk:** 42

**Serious Number At Risk:** 42

**Title:** Standard Care

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 38

**Group ID:** BG001

**Value:** 42

**Group ID:** BG002

**Value:** 80

**Units:** Participants

### Group

**ID:** BG000

**Title:** Polyurethane Foam

**Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker

### Group

**ID:** BG001

**Title:** Standard Care

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.27

**Value:** 11.79

#### Measurement

**Group ID:** BG001

**Spread:** 1.44

**Value:** 11.64

#### Measurement

**Group ID:** BG002

**Spread:** 1.35

**Value:** 11.71

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 31

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 49

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 37

#### Measurement

**Group ID:** BG001

**Value:** 39

#### Measurement

**Group ID:** BG002

**Value:** 76

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 23

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** type of surgery:Calcaneal Osteotomy
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** type of analgesia:peripheral nerve blocks analgesia
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** cristiana.forni@ior.it
**Organization:** Istituto Ortopedico Rizzoli
**Phone:** 0516366694
**Phone Extension:** 0039
**Title:** Head of the Research Nursing Unit
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** every day until discharge (expected average of 3 days)
**Title:** Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
**ID:** OG000
**Title:** Polyurethane Foam
##### Group
**ID:** OG001
**Title:** Standard Care
#### Outcome Measure 2
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** up to the first 3 days post intervention
**Title:** Pain (Score on the "Numeric Rating Scale")
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
**ID:** OG000
**Title:** Polyurethane Foam
##### Group
**ID:** OG001
**Title:** Standard Care
### Participant Flow Module
#### Group
**Description:** polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
**ID:** FG000
**Title:** Polyurethane Foam
#### Group
**Description:** Only application of the Walker in the immediate postoperative period.
**ID:** FG001
**Title:** Standard Care
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 38
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 42
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 38
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 42
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Recruitment Details:** The study began on May 2014 and ended in May 2015 when the eighties patient was enrolled.
**Has Results:** True