Polyurethane Foam on the Heel for Prevention in Children

NCT03039179 | Completed Results

• 1 other identifier: 0024520
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Flat Foot; Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain (Score on the "Numeric Rating Scale")

  up to the first 3 days post intervention

Study Arms (2)

Polyurethane foam

EXPERIMENTAL

Device: polyurethane foam dress

standard care

NO INTERVENTION

Only application of the Walker in the immediate postoperative period.

Interventions

polyurethane foam dress DEVICE

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

Polyurethane foam

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged \> 3 years underwent surgery for flat foot
• Children with intact skin at the heel

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

MeSH Terms

Conditions

Flatfoot; Pressure Ulcer

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Head of the Research Nursing Unit
• Organization: Istituto Ortopedico Rizzoli

cristiana.forni@ior.it

0516366694

Study Officials

• Caterina Guerra, RN

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 1, 2017
• Study Start: July 1, 2014
• Primary Completion: July 31, 2015
• Study Completion: August 31, 2015
• Last Updated: February 5, 2020
• Results First Posted: March 22, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share