The effect of locally applied platelet-rich fibrin on donor sites and recipient sites after split-thickness skin transplantation

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Patricia Danielsen
Scientific

Bispebjerg Hospital
Afdeling K
Bispebjerg Bakke 23
2400 Kobenhavn NV
2400
Denmark

Phone	+45 (0)3531 3463
Email	patriciadanielsen@yahoo.dk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The Donor Study
Study objectives	Platelet-rich fibrin shortens wound healing time and improves aesthetic outcome
Ethics approval(s)	Yes, 19/09/2005, ref: (KF)01286728
Health condition(s) or problem(s) studied	Chronic leg ulcer
Intervention	Split-thickness skin transplantation
Intervention type	Other
Primary outcome measure(s)	Epithelialization on day five and nine post-operatively
Key secondary outcome measure(s)	1. Clinical appearance 2. Histological evaluation 3. Transepidermal Water Loss (TEWL) 4. Erythema 5. Microbiology 6. Incidence of infection 7. Unwanted side effects 8. Temperature difference between treated patients and control group patients
Completion date	01/04/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Patients undergoing surgery for chronic leg ulcer 2. Aged over 18 years 3. Written informed consent, the patient is expected to be able to complete the study 4. Donor site area from 2 x (3 cm x 5 cm) to 2 x (7.6 cm x 15 cm)
Key exclusion criteria	1. Non-Danish speaking 2. Dementia 3. Pregnant or breastfeeding women 4. Patients treated with 10 mg of steroid or more daily 5. Patients that have received thrombocyte-inhibiting medicine less than four days before surgery 6. Patients not suited for general or spinal anaesthesia 7. Patients whose donor site has been used as a donor site before 8. Patients with skin diseases or pathological changes in the skin, including infection
Date of first enrolment	01/01/2006
Date of final enrolment	01/04/2007

Bispebjerg Hospital

2400 Kobenhavn NV
2400
Denmark

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2008		Yes	No
Results article	results	01/05/2013		Yes	No