Influence of Platelet Concentrates on Wound Healing

September 11, 2018 updated by: Paulmann, Anastasia, Hannover Medical School

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medical School Hannover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Closure
Time Frame: 4 weeks
Area of wound closure in % compared to initial size
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Flow
Time Frame: 4 weeks
Blood flow measured in wound margins and wound bed compared to regular skin measured using Laser Doppler Imaging
4 weeks
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
21 days
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
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

September 9, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (ACTUAL)

September 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #1055-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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