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Influence of Platelet Concentrates on Wound Healing

Primary Purpose

Platelet-Rich Plasma, Wound Healing Delayed

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Platelet-Rich Plasma
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platelet-Rich Plasma focused on measuring Platelet-Rich Plasma, Laser Doppler Imaging, Growth Factors, Wound Healing, Chronic wound healing disorder, Wound quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical School Hannover

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP Intervention

Arm Description

PRP injection into wound border

Outcomes

Primary Outcome Measures

Wound Closure
Area of wound closure in % compared to initial size

Secondary Outcome Measures

Blood Flow
Blood flow measured in wound margins and wound bed compared to regular skin measured using Laser Doppler Imaging
Wound Quality of Life
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
Ease of surgical wound closure
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

Full Information

First Posted
September 9, 2018
Last Updated
September 11, 2018
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03667638
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hannover Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP Intervention
Arm Type
Experimental
Arm Description
PRP injection into wound border
Intervention Type
Combination Product
Intervention Name(s)
Platelet-Rich Plasma
Other Intervention Name(s)
PRP, PMC
Intervention Description
Adding PRP to wound bed during surgical debridement
Primary Outcome Measure Information:
Title
Wound Closure
Description
Area of wound closure in % compared to initial size
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Blood Flow
Description
Blood flow measured in wound margins and wound bed compared to regular skin measured using Laser Doppler Imaging
Time Frame
4 weeks
Title
Wound Quality of Life
Description
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
Time Frame
21 days
Title
Ease of surgical wound closure
Description
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
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Vogt, MD
Organizational Affiliation
Medical School Hannover
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical School Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Influence of Platelet Concentrates on Wound Healing

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