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OpenTrials
Completed

NCT Number: NCT00856934

Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

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.

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Key information

Conditions

Skin Graft Burns Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Autologous Platelet Rich Plasma

Biological

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

Keratinocyte suspension

Biological

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

Standard dressings

Other

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

Primary outcomes

  1. Complete Wound Healing

    Time frame: Post operative day 5 and every other day thereafter

    Time required for complete epithelialization in days

Secondary outcomes

  1. Pain

    Time frame: Post operative day 5

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
First posted
Mar 6, 2009
Registry last updated
Mar 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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