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Skin GraftPhase 1NCT00856934

Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

A Phase 1 study testing Autologous Platelet Rich Plasma, Keratinocyte suspension and Standard dressings in people with Skin Graft, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective randomized trial evaluated the impact of autologous keratinocytes suspended in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that the treatment would speed and improve wound healing. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Skin Graft
What is being tested?
Autologous Platelet Rich Plasma, Keratinocyte suspension and Standard dressings
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSwitzerland
Study dates
Jun 2005to Mar 2006
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Skin graft donor sites total surface < 15% BSA
  • Skin graft donor site size: 0.2mm deep, 30 to 40 cm2 surface area

Who cannot join

  • Patients treated with immunosuppressors
  • Patients treated with corticoids
  • Patients suffering from terminal renal insufficiency
  • Patients suffering from severe peripheral arteriopathy

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Centre hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: A New Model to Enhance Wound Healing Using Autologous Keratinocytes in Platelet Concentrates - a Prospective Randomized Trial.

This prospective randomized trial evaluated the impact of autologous keratinocytes suspended in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that the treatment would speed and improve wound healing.

Conditions
Skin Graft
Being tested
Autologous Platelet Rich Plasma, Keratinocyte suspension, Standard dressings
Keywords
Skin graft donor site healing, skin, wound, platelet concentrate, keratinocytes, burns
Medical subject headings
Wounds and Injuries, Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Platelet Rich PlasmaBiological

    Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.

  • Keratinocyte suspensionBiological

    Autologous keratinocytes isolated from skin biopsy suspended in platelet rich plasma before spraying.

  • Standard dressingsOther

    Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.

Study groups in NCT00856934
Study groupRoleWhat they receive
ControlNo interventionWounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
Receives: Other: Standard dressings
PRPExperimentalPRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
Receives: Biological: Autologous Platelet Rich Plasma; Other: Standard dressings
PRP+KExperimentalKeratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
Receives: Biological: Autologous Platelet Rich Plasma; Biological: Keratinocyte suspension; Other: Standard dressings

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Wound Healing

    Time required for complete epithelialization in days

    Measured: Post operative day 5 and every other day thereafter

Secondary outcomes (1)

  1. Pain

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

    Measured: Post operative day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2009 (estimated)
  2. Study startJun 2005
  3. Primary completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00856934
Sponsor's protocol ID
132/03
Status last verified
Feb 2009
First submitted
2 Jan 2009
Last updated
6 Mar 2009
Data monitoring committee
No

Publications

  • Fu X, Li X, Cheng B, Chen W, Sheng Z. Engineered growth factors and cutaneous wound healing: success and possible questions in the past 10 years. Wound Repair Regen. 2005 Mar-Apr;13(2):122-30. doi: 10.1111/j.1067-1927.2005.130202.x.

    PubMed 15828936

  • Ansel JC, Tiesman JP, Olerud JE, Krueger JG, Krane JF, Tara DC, Shipley GD, Gilbertson D, Usui ML, Hart CE. Human keratinocytes are a major source of cutaneous platelet-derived growth factor. J Clin Invest. 1993 Aug;92(2):671-8. doi: 10.1172/JCI116636.

    PubMed 8349805

  • Ballaun C, Weninger W, Uthman A, Weich H, Tschachler E. Human keratinocytes express the three major splice forms of vascular endothelial growth factor. J Invest Dermatol. 1995 Jan;104(1):7-10. doi: 10.1111/1523-1747.ep12613450.

    PubMed 7798644

  • Brown LF, Yeo KT, Berse B, Yeo TK, Senger DR, Dvorak HF, van de Water L. Expression of vascular permeability factor (vascular endothelial growth factor) by epidermal keratinocytes during wound healing. J Exp Med. 1992 Nov 1;176(5):1375-9. doi: 10.1084/jem.176.5.1375.

    PubMed 1402682

  • Decline F, Rousselle P. Keratinocyte migration requires alpha2beta1 integrin-mediated interaction with the laminin 5 gamma2 chain. J Cell Sci. 2001 Feb;114(Pt 4):811-23. doi: 10.1242/jcs.114.4.811.

    PubMed 11171386

  • Feliciani C, Gupta AK, Sauder DN. Keratinocytes and cytokine/growth factors. Crit Rev Oral Biol Med. 1996;7(4):300-18. doi: 10.1177/10454411960070040101.

    PubMed 8986393

  • McKay IA, Leigh IM. Epidermal cytokines and their roles in cutaneous wound healing. Br J Dermatol. 1991 Jun;124(6):513-8. doi: 10.1111/j.1365-2133.1991.tb04942.x.

    PubMed 2064935

  • Tamariz-Dominguez E, Castro-Munozledo F, Kuri-Harcuch W. Growth factors and extracellular matrix proteins during wound healing promoted with frozen cultured sheets of human epidermal keratinocytes. Cell Tissue Res. 2002 Jan;307(1):79-89. doi: 10.1007/s004410100450. Epub 2001 Nov 14.

    PubMed 11810316

  • Carter CA, Jolly DG, Worden CE Sr, Hendren DG, Kane CJ. Platelet-rich plasma gel promotes differentiation and regeneration during equine wound healing. Exp Mol Pathol. 2003 Jun;74(3):244-55. doi: 10.1016/s0014-4800(03)00017-0.

    PubMed 12782011

  • Knighton DR, Ciresi KF, Fiegel VD, Austin LL, Butler EL. Classification and treatment of chronic nonhealing wounds. Successful treatment with autologous platelet-derived wound healing factors (PDWHF). Ann Surg. 1986 Sep;204(3):322-30. doi: 10.1097/00000658-198609000-00011.

    PubMed 3753059

  • Mazzucco L, Medici D, Serra M, Panizza R, Rivara G, Orecchia S, Libener R, Cattana E, Levis A, Betta PG, Borzini P. The use of autologous platelet gel to treat difficult-to-heal wounds: a pilot study. Transfusion. 2004 Jul;44(7):1013-8. doi: 10.1111/j.1537-2995.2004.03366.x.

    PubMed 15225241

  • Valbonesi M, Giannini G, Migliori F, Dalla Costa R, Galli A. The role of autologous fibrin-platelet glue in plastic surgery: a preliminary report. Int J Artif Organs. 2002 Apr;25(4):334-8. doi: 10.1177/039139880202500413.

    PubMed 12027145

  • Brissett AE, Hom DB. The effects of tissue sealants, platelet gels, and growth factors on wound healing. Curr Opin Otolaryngol Head Neck Surg. 2003 Aug;11(4):245-50. doi: 10.1097/00020840-200308000-00005.

    PubMed 14515071

  • Feldman DL. Which dressing for split-thickness skin graft donor sites? Ann Plast Surg. 1991 Sep;27(3):288-91. doi: 10.1097/00000637-199109000-00017.

    PubMed 1952757

  • Gharaee-Kermani M, Phan SH. Role of cytokines and cytokine therapy in wound healing and fibrotic diseases. Curr Pharm Des. 2001 Jul;7(11):1083-103. doi: 10.2174/1381612013397573.

    PubMed 11472255

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous Platelet Rich Plasma, Keratinocyte suspension and Standard dressings in people with Skin Graft, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Wound Healing (time frame: Post operative day 5 and every other day thereafter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00856934, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2009.

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