N/A N=80 Randomized Prevention

Polyurethane Foam on the Heel for Prevention in Children

Flat Foot · Pressure Ulcer

Bottom Line

View on ClinicalTrials.gov: NCT03039179 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) — 17; 21 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: polyurethane foam dress (Device)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: Istituto Ortopedico Rizzoli
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)	17; 21	—
SECONDARY Pain (Score on the "Numeric Rating Scale")	26; 25	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03039179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.