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Completed

NCT Number: NCT03667638

Influence of Platelet Concentrates on Wound Healing

Chronic soft tissues defects can extend into the fat layer or even deeper and can cause functional disadvantages. Split-thickness skin grafts (STSGs) used to cover these wounds have varying success rates. To improve wound healing in chronic wounds the authors have studied the application of autologous platelet concentrates in a human keratinocyte culture model in vitro and in a combination with surgical procedures in vivo as second line therapy in patients with initially failed wound closure.

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Key information

Conditions

Platelet-Rich Plasma Wound Healing Delayed

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical School Hannover

Hanover, Lower Saxony, 30625, Germany

About this study

For in vitro testing on keratinocytes a platelet-mediator concentrate (PMC) was processed with a commercially available bed-side system (ATR®, Curasan, Germany). In a clinical study soft tissue defects (n=5) were treated using a combination of surgical debridement and autologous platelet rich plasma (PRP). Time of healing as determined by epithelization as well as Laser Doppler Imaging to visualize blood flow were analyzed. Additionally, changes in "ease of surgical wound closure" were determined. Finally, the quality of life of patients was assessed using a validated questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • exposed tendons, ligaments or bone for >3 weeks
  • no healing tendency

Exclusion criteria

  • sepsis
  • intensive care treatment
  • continuous smoking
  • pregnancy or breast feeding women
  • participants of other studies.

Treatment and study plan

platelet-rich plasma

Combination Product

Adding PRP to wound bed during surgical debridement

Other names: PRP, PMC

Primary outcomes

  1. Wound Closure

    Time frame: 4 weeks

    Area of wound closure in % compared to initial size

Secondary outcomes

  1. Blood Flow

    Time frame: 4 weeks

    Blood flow measured in wound margins and wound bed compared to regular skin measured using Laser Doppler Imaging

  2. Wound Quality of Life

    Time frame: 21 days

    Quality of patients' life measured using Wound-QoL® Questionnaire before and after Intervention. Seventeen items are included in the Wound-QoL, which could be attributed to three subscales on everyday life, body, and psyche. The paper presents the overall score. A higher value correlates with more wound related burden, meaning a lower value indicates higher qulitiy of life.

    More information: https://www.ncbi.nlm.nih.gov/pubmed/24899053

  3. Ease of surgical wound closure

    Time frame: 21 days

    Estimated ease of surgical wound closure. The patients'wound was discussed by at least two surgeons to obtain agreement on a 14- point "Ease of Closure" scale. This was done on day 0 as well as day 21. The scale ranged from a score of 0, meaning the wound was closed or so small as to require no closure technique, to a score of 13, meaning that it was not possible to close the wound with known reconstructive surgical techniques. A higher value therefore correlates with more complex surgery.

    More information: https://www.ncbi.nlm.nih.gov/pubmed/10231510

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

The Influence of Autologous Platelet Concentrates on Human Keratinocyte Proliferation in Vitro and Wound Healing in Vivo

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2018
Registry last updated
Sep 12, 2018

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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