Trial Outcomes & Findings for Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities (NCT NCT00858442)

Results Overview

Participants were followed from the date of surgery and the date of onset of compression for a minimum of 13.5 days and a maximum of 27 days

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

day

Results posted on

2015-02-13

Participant Flow

Participants were recruited on the day of the scheduled surgery. The researcher checked the inclusion criteria. Explained to the parents and patient surgical procedure, risk of complications and are invited to participate voluntarily in the study. Informed consent is signed. They recruited 44 children in total between April 6,2009 and August 9,2011

Potential candidates to enter the study were 80. Of these, 20 were excluded for having a weight less than 35 kg; 15 for failing to ensure their attendance at the controls and 1 have coagulation disorders

Participant milestones

Participant milestones
Measure	Without PRP This arm did not receive any intervention	With PRP 4 cc of PRP is evenly distributed before the dermo-epidermic draft.
From Surgery to Start Compression; STARTED	21	23
From Surgery to Start Compression; COMPLETED	21	23
From Surgery to Start Compression; NOT COMPLETED	0	0
Compression:Start to Finish STARTED	21	23
Compression:Start to Finish COMPLETED	20	20
Compression:Start to Finish NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Without PRP This arm did not receive any intervention	With PRP 4 cc of PRP is evenly distributed before the dermo-epidermic draft.
Compression:Start to Finish Lost to Follow-up	1	3

Baseline Characteristics

Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Without PRP n=21 Participants Patients with burns sequelae on their limbs treated with release of burns contractures and skin graft between 2008-2010.	With PRP n=23 Participants Patients with burns sequelae on their limbs treated with release of burn contractures and skin graft with PRP between 2008-2010.	Total n=44 Participants Total of all reporting groups
Age, Continuous	14.5 years STANDARD_DEVIATION 3.1 • n=5 Participants	14.1 years STANDARD_DEVIATION 3.5 • n=7 Participants	14.2 years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Chile	21 participants n=5 Participants	23 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: day

Population: A participant may have one, two or three areas grafted

Participants were followed from the date of surgery and the date of onset of compression for a minimum of 13.5 days and a maximum of 27 days

Outcome measures

Outcome measures
Measure	Without PRP n=26 grafted area Patients did not received plasma enrich platelets	With PRP n=33 grafted area Patients received plasma enriched platelets
Median Time Between Surgery Date and Start Date Compression.	17 day Interval 14.0 to 24.0	19 day Interval 13.5 to 27.0

SECONDARY outcome

Timeframe: start and end compression

Central width measurement graft between the start and the end of the compression

Outcome measures

Outcome measures
Measure	Without PRP n=26 grafted areas Patients did not received plasma enrich platelets	With PRP n=33 grafted areas Patients received plasma enriched platelets
Width of the Graft	0.1 centimeter Interval -0.25 to 1.35	0.3 centimeter Interval -0.5 to 2.05

SECONDARY outcome

Timeframe: start and end compression

Central length measurement graft between the start and the end of the compression

Outcome measures

Outcome measures
Measure	Without PRP n=26 grafted areas Patients did not received plasma enrich platelets	With PRP n=33 grafted areas Patients received plasma enriched platelets
Length of the Graft	0.2 centimeter Interval -0.95 to 1.55	0.2 centimeter Interval -0.65 to 1.0

Adverse Events

Without PRP

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

With PRP

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Without PRP n=21 participants at risk Patients did not receive plasma enriched platelets	With PRP n=23 participants at risk Patients received plasma enriched platelets
Surgical and medical procedures regrafting	4.8% 1/21 • Number of events 1 • 2 months adverse effect is considered the need regrafting bloody small areas.	4.3% 1/23 • Number of events 1 • 2 months adverse effect is considered the need regrafting bloody small areas.

Other adverse events

Adverse event data not reported

Additional Information

M Beatriz Quezada.MD

coaniquem

Phone: 56-2-28734077

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place