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Platelet-Rich PlasmaNCT03667638

Influence of Platelet Concentrates on Wound Healing

A study testing Platelet-Rich Plasma in people with Platelet-Rich Plasma and Wound Healing Delayed, run by Hannover Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Platelet-Rich Plasma, Wound Healing Delayed
What is being tested?
Platelet-Rich Plasma
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteGermany
Study dates
Nov 2016to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Medical School Hannover

    Hanover, Lower Saxony, 30625

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Platelet-Rich Plasma
Keywords
Platelet-Rich Plasma, Laser Doppler Imaging, Growth Factors, Wound Healing, Chronic wound healing disorder, Wound quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet-Rich PlasmaCombination product

    Also called PRP, PMC

    Adding PRP to wound bed during surgical debridement

Study groups in NCT03667638
Study groupRoleWhat they receive
PRP InterventionExperimentalPRP injection into wound border
Receives: Combination Product: Platelet-Rich Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound Closure

    Area of wound closure in % compared to initial size

    Measured: 4 weeks

Secondary outcomes (3)

  1. Blood Flow

    Blood flow measured in wound margins and wound bed compared to regular skin measured using Laser Doppler Imaging

    Measured: 4 weeks

  2. 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

    Measured: 21 days

  3. 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

    Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study startNov 2016
  3. Primary completionNov 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03667638
Sponsor's protocol ID
#1055-2011
Status last verified
Sep 2018
First submitted
9 Sep 2018
Last updated
12 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Danielsen P, Jorgensen B, Karlsmark T, Jorgensen LN, Agren MS. Effect of topical autologous platelet-rich fibrin versus no intervention on epithelialization of donor sites and meshed split-thickness skin autografts: a randomized clinical trial. Plast Reconstr Surg. 2008 Nov;122(5):1431-1440. doi: 10.1097/PRS.0b013e318188202c.

    PubMed 18971727

  • Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney JA, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future research. J Am Geriatr Soc. 2015 Mar;63(3):427-38. doi: 10.1111/jgs.13332. Epub 2015 Mar 6.

    PubMed 25753048

  • Asadi M, Alamdari DH, Rahimi HR, Aliakbarian M, Jangjoo A, Abdollahi A, Bahar MM, Azadmand A, Forghani N, Sadegh MN, Khayamy ME, Seifalian A. Treatment of life-threatening wounds with a combination of allogenic platelet-rich plasma, fibrin glue and collagen matrix, and a literature review. Exp Ther Med. 2014 Aug;8(2):423-429. doi: 10.3892/etm.2014.1747. Epub 2014 May 29.

    PubMed 25009595

  • Behm B, Babilas P, Landthaler M, Schreml S. Cytokines, chemokines and growth factors in wound healing. J Eur Acad Dermatol Venereol. 2012 Jul;26(7):812-20. doi: 10.1111/j.1468-3083.2011.04415.x. Epub 2011 Dec 26.

    PubMed 22211801

  • Alsousou J, Thompson M, Hulley P, Noble A, Willett K. The biology of platelet-rich plasma and its application in trauma and orthopaedic surgery: a review of the literature. J Bone Joint Surg Br. 2009 Aug;91(8):987-96. doi: 10.1302/0301-620X.91B8.22546.

    PubMed 19651823

  • Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. doi: 10.1152/physrev.2003.83.3.835.

    PubMed 12843410

  • Carter CA, Jolly DG, Worden CE Sr, Hendren DG, Kane CJ. Platelet-rich plasma gel promotes differentiation and regeneration during equine wound healing. Exp Mol Pathol. 2003 Jun;74(3):244-55. doi: 10.1016/s0014-4800(03)00017-0.

    PubMed 12782011

  • Achora S, Muliira JK, Thanka AN. Strategies to promote healing of split thickness skin grafts: an integrative review. J Wound Ostomy Continence Nurs. 2014 Jul-Aug;41(4):335-9; quiz E1-2. doi: 10.1097/WON.0000000000000035.

    PubMed 24988511

  • Appel TR, Potzsch B, Muller J, von Lindern JJ, Berge SJ, Reich RH. Comparison of three different preparations of platelet concentrates for growth factor enrichment. Clin Oral Implants Res. 2002 Oct;13(5):522-8. doi: 10.1034/j.1600-0501.2002.130512.x.

    PubMed 12453130

  • Cohn CS, Lockhart E. Autologous platelet-rich plasma: evidence for clinical use. Curr Opin Hematol. 2015 Nov;22(6):527-32. doi: 10.1097/MOH.0000000000000183.

    PubMed 26390166

  • Berg L, Meyer S, Ipaktchi R, Vogt PM, Muller A, de Zwaan M. [Psychosocial Distress at Different Time Intervals after Burn Injury]. Psychother Psychosom Med Psychol. 2017 Jun;67(6):231-239. doi: 10.1055/s-0042-111006. Epub 2016 Sep 29. German.

    PubMed 27685256

  • House SL. Psychological distress and its impact on wound healing: an integrative review. J Wound Ostomy Continence Nurs. 2015 Jan-Feb;42(1):38-41. doi: 10.1097/WON.0000000000000080.

    PubMed 25549307

  • Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.

    PubMed 24899053

  • Weibrich G, Kleis WK. Curasan PRP kit vs. PCCS PRP system. Collection efficiency and platelet counts of two different methods for the preparation of platelet-rich plasma. Clin Oral Implants Res. 2002 Aug;13(4):437-43. doi: 10.1034/j.1600-0501.2002.130413.x.

    PubMed 12175382

  • Weibrich G, Kleis WK, Hafner G, Hitzler WE, Wagner W. Comparison of platelet, leukocyte, and growth factor levels in point-of-care platelet-enriched plasma, prepared using a modified Curasan kit, with preparations received from a local blood bank. Clin Oral Implants Res. 2003 Jun;14(3):357-62. doi: 10.1034/j.1600-0501.2003.00810.x.

    PubMed 12755786

Questions about this trial

What is this clinical trial studying?

A study testing Platelet-Rich Plasma in people with Platelet-Rich Plasma and Wound Healing Delayed, run by Hannover Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound Closure (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03667638, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.

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