Trial Outcomes & Findings for Polyurethane Foam on the Heel for Prevention in Children (NCT NCT03039179)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

every day until discharge (expected average of 3 days)

Results posted on

2020-02-05

Participant Flow

The study began on May 2014 and ended in May 2015 when the eighties patient was enrolled.

Participant milestones

Participant milestones
Measure	Polyurethane Foam polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker	Standard Care Only application of the Walker in the immediate postoperative period.
Overall Study STARTED	38	42
Overall Study COMPLETED	38	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Polyurethane Foam on the Heel for Prevention in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polyurethane Foam n=38 Participants polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker	Standard Care n=42 Participants	Total n=80 Participants Total of all reporting groups
Age, Continuous	11.79 years STANDARD_DEVIATION 1.27 • n=5 Participants	11.64 years STANDARD_DEVIATION 1.44 • n=7 Participants	11.71 years STANDARD_DEVIATION 1.35 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
type of surgery:Calcaneal Osteotomy	37 Participants n=5 Participants	39 Participants n=7 Participants	76 Participants n=5 Participants
type of analgesia:peripheral nerve blocks analgesia	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polyurethane Foam n=38 Participants polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker	Standard Care n=42 Participants
Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)	17 Participants	21 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Polyurethane Foam n=38 Participants polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker	Standard Care n=42 Participants
Pain (Score on the "Numeric Rating Scale")	26 Participants	25 Participants

Adverse Events

Polyurethane Foam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Head of the Research Nursing Unit

Istituto Ortopedico Rizzoli

Phone: 0516366694

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place