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
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
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
NCT ID
NCT03526913
First Posted
May 4, 2018
Last Updated
May 16, 2018
Sponsor
Noha Mohsen Omar
Collaborators
Menoufia University
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
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PubMed Identifier
12843410
Citation
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PubMed Identifier
15509939
Citation
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PubMed Identifier
19482315
Citation
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Results Reference
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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.
Results Reference
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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
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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.
Results Reference
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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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