Clinical trial NCT03667638: Influence of Platelet Concentrates on Wound Healing
Official title: The Influence of Autologous Platelet Concentrates on Human Keratinocyte Proliferation in Vitro and Wound Healing in Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet-Rich Plasma
Wound Healing Delayed
Keywords: Platelet-Rich Plasma
Laser Doppler Imaging
Growth Factors
Wound Healing
Chronic wound healing disorder
Wound quality of life
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wound Closure
timeFrame: 4 weeks
Secondary outcomes:
measure: Blood Flow
timeFrame: 4 weeks
measure: Wound Quality of Life
timeFrame: 21 days
measure: Ease of surgical wound closure
timeFrame: 21 days
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover
state: Niedersachsen
Study officials:
affiliation: Medical School Hannover
name: Peter Vogt, MD
role: PRINCIPAL_INVESTIGATOR
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