Condition category
Circulatory System
Date applied
09/01/2006
Date assigned
17/02/2006
Last edited
24/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Patricia Danielsen

ORCID ID

Contact details

Bispebjerg Hospital
Afdeling K
Bispebjerg Bakke 23
2400 Kobenhavn NV
2400
Denmark
+45 (0)3531 3463
patriciadanielsen@yahoo.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

(KF) 01286728

Study information

Scientific title

Acronym

The Donor Study

Study hypothesis

Platelet-rich fibrin shortens wound healing time and improves aesthetic outcome

Ethics approval

Yes, 19/09/2005, ref: (KF)01286728

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Chronic leg ulcer

Intervention

Split-thickness skin transplantation

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Epithelialization on day five and nine post-operatively

Secondary outcome measures

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

Overall trial start date

01/01/2006

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

01/04/2007

Locations

Countries of recruitment

Denmark

Trial participating centre

Bispebjerg Hospital
2400 Kobenhavn NV
2400
Denmark

Sponsor information

Organisation

Vivolution A/S (Denmark)

Sponsor details

Blokken 45
3460 Birkeroed
3460
Denmark
+45 (0)4581 1962
info@vivolution.dk

Sponsor type

Industry

Website

http://www.vivolution.com

Funders

Funder type

Industry

Funder name

Vivolution A/S (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18971727
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22987230

Publication citations

  1. Results

    Danielsen P, Jørgensen B, Karlsmark T, Jorgensen LN, Agren MS, Effect of topical autologous platelet-rich fibrin versus no intervention on epithelialization of donor sites and meshed split-thickness skin autografts: a randomized clinical trial., Plast. Reconstr. Surg., 2008, 122, 5, 1431-1440, doi: 10.1097/PRS.0b013e318188202c.

  2. Results

    Danielsen PL, Jorgensen LN, Jørgensen B, Karlsmark T, Agren MS, Erythema persists longer than one year in split-thickness skin graft donor sites., Acta Derm. Venereol., 2013, 93, 3, 281-285, doi: 10.2340/00015555-1455.

Additional files

Editorial Notes