Flat Foot, Pressure Ulcer
Conditions
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.
Interventions
DEVICEpolyurethane foam dress
Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) | every day until discharge (expected average of 3 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain (Score on the Numeric Rating Scale) | up to the first 3 days post intervention | 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. |
Participant flow
Recruitment details
The study began on May 2014 and ended in May 2015 when the eighties patient was enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Polyurethane Foam polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker | 38 |
| Standard Care | 42 |
| Total | 80 |
Baseline characteristics
| Characteristic | Standard Care | Polyurethane Foam | Total |
|---|---|---|---|
| Age, Continuous | 11.64 years STANDARD_DEVIATION 1.44 | 11.79 years STANDARD_DEVIATION 1.27 | 11.71 years STANDARD_DEVIATION 1.35 |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 26 Participants | 23 Participants | 49 Participants |
| type of analgesia:peripheral nerve blocks analgesia | 13 Participants | 10 Participants | 23 Participants |
| type of surgery:Calcaneal Osteotomy | 39 Participants | 37 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 42 |
| other Total, other adverse events | 0 / 38 | 0 / 42 |
| serious Total, serious adverse events | 0 / 38 | 0 / 42 |
Outcome results
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.
Time frame: every day until discharge (expected average of 3 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polyurethane Foam | Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) | 17 Participants |
| Standard Care | Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) | 21 Participants |
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.
Time frame: up to the first 3 days post intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polyurethane Foam | Pain (Score on the Numeric Rating Scale) | 26 Participants |
| Standard Care | Pain (Score on the Numeric Rating Scale) | 25 Participants |