Influence of Platelet Concentrates on Wound Healing

Not Applicable

Completed

• Conditions: Platelet-Rich Plasma; Wound Healing Delayed
• Interventions: Combination Product: Platelet-Rich Plasma

• Registration Number: NCT03667638
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Study Start: 2016-11
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Status Verified: 2018-09
• Study First Submitted: 2018-09-09
• Study First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-11
• Study First Posted: 2018-09-12
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRP Intervention	Platelet-Rich Plasma	PRP injection into wound border

Primary Outcome Measures

Name	Time	Method
Wound Closure	4 weeks	Area of wound closure in % compared to initial size

Secondary Outcome Measures

Name	Time	Method
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
Blood Flow	4 weeks	Blood flow measured in wound margins and wound bed compared to regular skin measured using Laser Doppler Imaging
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

Trial Locations

Locations (1)

Medical School Hannover; 🇩🇪 Hannover, Niedersachsen, Germany