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Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers

Primary Purpose

Chronic Venous Hypertension With Ulcer and Inflammation, Chronic Ulcer of Leg or Foot

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRP
STSG
Sponsored by
Noha Mohsen Omar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Hypertension With Ulcer and Inflammation focused on measuring chronic leg ulcers, PRP, split-thickness skin graft, platelet-rich plasma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria:

  • Patients with chronic ulcers for at least 6 months.
  • Age ≧ 12 years.

Exclusion criteria:

  • Patients younger than 12 years of age.
  • Patients with diabetes or other diseases affecting tissue healing.
  • Patients with current ongoing pathologies in arterial or venous systems.
  • Patients with malignant ulcers.
  • Patients on corticosteroids or other drugs affecting tissue healing.
  • Patients with unrealistic expectations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PRP + STSG

    STSG Split Thickness Skin Graft

    Arm Description

    autologous PRP treatments every week prior to graft placement (STSG)

    skin graft (STSG) (intervention)

    Outcomes

    Primary Outcome Measures

    Graft take
    percentage of graft take

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2018
    Last Updated
    May 16, 2018
    Sponsor
    Noha Mohsen Omar
    Collaborators
    Menoufia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03526913
    Brief Title
    Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers
    Official Title
    Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    September 1, 2017 (Actual)
    Study Completion Date
    February 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Noha Mohsen Omar
    Collaborators
    Menoufia University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Chronic venous ulcers are considered a problem with a big morbidity impact on both the health facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers. In this study, the investigators compare combining autologous platelet rich plasma treatments with partial skin grafting in chronic ulcers, the results were compared to using only partial skin grafting, and among various types of chronic resistant ulcers.
    Detailed Description
    Fourteen patients had bilateral lower limb ulcers, and 6 of them had single large ulcers as follows; Fourteen patients with chronic venous ulcers (12 of which had bilateral ulcers, 2 had single large ulcers) Four patients, each with a single chronic post-traumatic ulcer Two patients with bilateral chronic lymphatic ulcers. After detailed history, physical examination and investigations (such as duplex), Each patient with bilateral ulcers included in the study (14 patients) received treatment A on one ulcer and treatment B on the other ulcer. In case of patients with single large ulcers (6 patients), treatment A was done on one half of the ulcer and treatment B on the other half of the ulcer (done in ulcers with an area greater than 10 x 10 cms). Treatment A included pre-operative intra-lesional PRP injections in 1-week intervals for 3 times, followed by intra-operative intra-lesional injection of PRP prior to meshed graft placement. PRP was injected into the ulcer bed and ulcer edges using a sterile syringe. Treatment B included only placement of meshed graft, with no PRP treatment. Pre-operative preparation: Ulcers were prepared by proper dressings and followed up until acquiring a clean bed. Debridement was done as needed to obtain clean base ready for graft placement. PRP preparation: 10 ml of blood was drawn from each patient intra operatively (autologous PRP). Blood was collected in sterile tubes, Anticoagulant Citrate Dextrose (ACD) was used for anticoagulation, which is the same substance used to preserve viable platelets in blood banks for platelet transfer. Tubes were centrifuged in Beckman Allerga X-12 centrifuge for 20 mins, 3000 rpm. Each 10 ml of blood yielded an average of 3-4 ml of PRP. Calcium gluconate was added in a ratio of 1:10 to PRP. Post-operative assessment was carried out by follow up clinical examination, photography and weekly biopsy samples.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Venous Hypertension With Ulcer and Inflammation, Chronic Ulcer of Leg or Foot
    Keywords
    chronic leg ulcers, PRP, split-thickness skin graft, platelet-rich plasma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    Comparison of combined autologous PRP and skin grafting to skin grafting alone in chronic leg ulcers (comparing one ulcer to another in bilateral cases, or one half of ulcer to the other in big ulcers)
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PRP + STSG
    Arm Type
    Experimental
    Arm Description
    autologous PRP treatments every week prior to graft placement (STSG)
    Arm Title
    STSG Split Thickness Skin Graft
    Arm Type
    Active Comparator
    Arm Description
    skin graft (STSG) (intervention)
    Intervention Type
    Procedure
    Intervention Name(s)
    PRP
    Other Intervention Name(s)
    platelet rich plasma
    Intervention Description
    PRP: autologous platelet-rich plasma
    Intervention Type
    Procedure
    Intervention Name(s)
    STSG
    Other Intervention Name(s)
    split thickness skin graft
    Intervention Description
    skin graft: Split Thickness Skin Grafting (STSG)
    Primary Outcome Measure Information:
    Title
    Graft take
    Description
    percentage of graft take
    Time Frame
    month

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Patients with chronic ulcers for at least 6 months. Age ≧ 12 years. Exclusion criteria: Patients younger than 12 years of age. Patients with diabetes or other diseases affecting tissue healing. Patients with current ongoing pathologies in arterial or venous systems. Patients with malignant ulcers. Patients on corticosteroids or other drugs affecting tissue healing. Patients with unrealistic expectations.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sherif M. Elkashty, PHD
    Organizational Affiliation
    Menoufia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Comparison of combined pre and intra-operative PRP treatments with STSG to only STSG in treatment of chronic ulcers with special emphasis on venous ulcers.
    IPD Sharing Time Frame
    infinite
    IPD Sharing Access Criteria
    to all researchers
    Citations:
    PubMed Identifier
    18222318
    Citation
    Fonder MA, Lazarus GS, Cowan DA, Aronson-Cook B, Kohli AR, Mamelak AJ. Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings. J Am Acad Dermatol. 2008 Feb;58(2):185-206. doi: 10.1016/j.jaad.2007.08.048.
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    PubMed Identifier
    12843410
    Citation
    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.
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    PubMed Identifier
    15509939
    Citation
    Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. 2004 Nov;114(6):1502-8. doi: 10.1097/01.prs.0000138251.07040.51.
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    PubMed Identifier
    19482315
    Citation
    Pietramaggiori G, Scherer SS, Mathews JC, Gennaoui T, Lancerotto L, Ragno G, Valeri CR, Orgill DP. Quiescent platelets stimulate angiogenesis and diabetic wound repair. J Surg Res. 2010 May 1;160(1):169-77. doi: 10.1016/j.jss.2008.09.010. Epub 2008 Oct 10.
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    PubMed Identifier
    18971718
    Citation
    Kakudo N, Minakata T, Mitsui T, Kushida S, Notodihardjo FZ, Kusumoto K. Proliferation-promoting effect of platelet-rich plasma on human adipose-derived stem cells and human dermal fibroblasts. Plast Reconstr Surg. 2008 Nov;122(5):1352-1360. doi: 10.1097/PRS.0b013e3181882046.
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    PubMed Identifier
    12654015
    Citation
    Schultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, Romanelli M, Stacey MC, Teot L, Vanscheidt W. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28. doi: 10.1046/j.1524-475x.11.s2.1.x.
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    PubMed Identifier
    26339534
    Citation
    Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.
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    PubMed Identifier
    2403699
    Citation
    Knighton DR, Ciresi K, Fiegel VD, Schumerth S, Butler E, Cerra F. Stimulation of repair in chronic, nonhealing, cutaneous ulcers using platelet-derived wound healing formula. Surg Gynecol Obstet. 1990 Jan;170(1):56-60.
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    Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers

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