Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers
May 16, 2018 updated by: Noha Mohsen Omar
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
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
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
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: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: PRP + STSG
autologous PRP treatments every week prior to graft placement (STSG)
|
PRP: autologous platelet-rich plasma
Other Names:
skin graft: Split Thickness Skin Grafting (STSG)
Other Names:
|
|
ACTIVE_COMPARATOR: STSG Split Thickness Skin Graft
skin graft (STSG) (intervention)
|
skin graft: Split Thickness Skin Grafting (STSG)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Graft take
Time Frame: month
|
percentage of graft take
|
month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sherif M. Elkashty, PHD, Menoufia University
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
- 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.
- 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.
- Raffetto JD, Khalil RA. Matrix metalloproteinases and their inhibitors in vascular remodeling and vascular disease. Biochem Pharmacol. 2008 Jan 15;75(2):346-59. doi: 10.1016/j.bcp.2007.07.004. Epub 2007 Jul 7.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
February 1, 2016
Primary Completion (ACTUAL)
September 1, 2017
Study Completion (ACTUAL)
February 1, 2018
Study Registration Dates
First Submitted
May 4, 2018
First Submitted That Met QC Criteria
May 4, 2018
First Posted (ACTUAL)
May 16, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 18, 2018
Last Update Submitted That Met QC Criteria
May 16, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 (Mobile Health and Wellness Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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