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Influence of Platelet Concentrates on Wound Healing

Sponsor
Hannover Medical School (Other)
Overall Status
Completed
CT.gov ID
NCT03667638
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
13
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Platelet-Rich Plasma
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Influence of Autologous Platelet Concentrates on Human Keratinocyte Proliferation in Vitro and Wound Healing in Vivo
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRP Intervention

PRP injection into wound border

Combination Product: Platelet-Rich Plasma
Adding PRP to wound bed during surgical debridement
Other Names:
  • PRP, PMC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Wound Closure [4 weeks]

      Area of wound closure in % compared to initial size

    Secondary Outcome Measures

    1. Blood Flow [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical School Hannover Hannover Niedersachsen Germany 30625

    Sponsors and Collaborators

    • Hannover Medical School

    Investigators

    • Principal Investigator: Peter Vogt, MD, Medical School Hannover

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Paulmann, Anastasia, Principal Investigator, Hannover Medical School
    ClinicalTrials.gov Identifier:
    NCT03667638
    Other Study ID Numbers:
    • #1055-2011
    First Posted:
    Sep 12, 2018
    Last Update Posted:
    Sep 12, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Paulmann, Anastasia, Principal Investigator, Hannover Medical School
    Platelet-Rich Plasma
    Laser Doppler Imaging
    Growth Factors
    Wound Healing
    Chronic wound healing disorder
    Wound quality of life
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Sep 12, 2018