Trial Outcomes & Findings for Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing (NCT NCT00856934)

NCT ID: NCT00856934

Last Updated: 2009-03-06

Results Overview

Time required for complete epithelialization in days

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 45 participants
• Primary outcome timeframe: Post operative day 5 and every other day thereafter
• Results posted on: 2009-03-06

Participant Flow

Participant milestones

Measure	Control Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.	PRP Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.	PRP+K Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
Overall Study STARTED	15	15	15
Overall Study COMPLETED	15	15	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

Baseline characteristics by cohort

Measure	Control n=15 Participants Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.	PRP n=15 Participants Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.	PRP+K n=15 Participants Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	41 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Age Continuous	42.5 years STANDARD_DEVIATION 11.9 • n=5 Participants	45.5 years STANDARD_DEVIATION 15.3 • n=7 Participants	46.9 years STANDARD_DEVIATION 20.5 • n=5 Participants	44.7 years STANDARD_DEVIATION 16.2 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	25 Participants n=4 Participants

PRIMARY outcome

Timeframe: Post operative day 5 and every other day thereafter

Time required for complete epithelialization in days

Outcome measures

Measure	Control n=15 Participants Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.	PRP n=15 Participants Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.	PRP+K n=15 Participants Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
Complete Wound Healing	13.9 Days Standard Deviation 2.0	7.2 Days Standard Deviation 0.8	5.7 Days Standard Deviation 0.7

SECONDARY outcome

Timeframe: Post operative day 5

Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement.

Outcome measures

Measure	Control n=15 Participants Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.	PRP n=15 Participants Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.	PRP+K n=15 Participants Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
Pain	7.2 VAS Pain Score Standard Deviation 0.7	1.5 VAS Pain Score Standard Deviation 0.9	0.4 VAS Pain Score Standard Deviation 0.7

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wassim Raffoul

CHUV - CPR

Phone: +41 21 314 25 05

Email: Wassim.Raffoul@chuv.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place