Pressure Ulcer Clinical Trial
— SCHIUMABIMBOfficial title:
Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial
NCT number | NCT03039179 |
Other study ID # | 0024520 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2014 |
Est. completion date | August 31, 2015 |
Verified date | April 2017 |
Source | Istituto Ortopedico Rizzoli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 31, 2015 |
Est. primary completion date | July 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | every day until discharge (expected average of 3 days) | |
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. | up to the first 3 days post intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03351049 -
An RCT on Support Surfaces for Pressure Ulcer Prevention
|
N/A | |
Completed |
NCT05112068 -
Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
|
||
Completed |
NCT05575869 -
Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students
|
N/A | |
Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
Terminated |
NCT05234632 -
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
|
N/A | |
Completed |
NCT04540822 -
Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care
|
N/A | |
Completed |
NCT02092870 -
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
|
Phase 2 | |
Terminated |
NCT01966380 -
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
|
Phase 2 | |
Completed |
NCT01438541 -
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
|
Phase 4 | |
Completed |
NCT00365430 -
SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
|
N/A | |
Completed |
NCT04251897 -
Novel Support Surface to Alleviate Pressure Ulcer
|
N/A | |
Completed |
NCT03391310 -
Use of Honey for Pressure Ulcers in Critically Ill Children
|
N/A | |
Recruiting |
NCT04559165 -
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
|
N/A | |
Completed |
NCT05646121 -
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
|
||
Not yet recruiting |
NCT06421454 -
Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
|
N/A | |
Terminated |
NCT05547191 -
Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement
|
N/A | |
Completed |
NCT05458050 -
An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers
|
N/A | |
Active, not recruiting |
NCT03048357 -
Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
|
N/A | |
Completed |
NCT06025370 -
Pressures During Prone Positions in Healthy Volunteers
|
N/A | |
Recruiting |
NCT05033470 -
A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers
|
N/A |