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

Chronic Ulcer of Leg or Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526913
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: May 2018
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Ulcer of Leg or Foot
• Chronic Venous Hypertension With Ulcer and Inflammation
• Inflammation
• Ulcer
• Varicose Ulcer

Intervention

Procedure:
• PRP
PRP: autologous platelet-rich plasma
• STSG
skin graft: Split Thickness Skin Grafting (STSG)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Noha Mohsen Omar	Menoufia University

References & Publications (9)

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. — View 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. Review. — View Citation

Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. Review. — View 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):1352-60. doi: 10.1097/PRS.0b013e3181882046. — View 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. — View 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. — View Citation

Raffetto JD, Khalil RA. Matrix metalloproteinases and their inhibitors in vascular remodeling and vascular disease. Biochem Pharmacol. 2008 Jan 15;75(2):346-59. Epub 2007 Jul 7. Review. — View 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. Review. — View Citation

Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft take	percentage of graft take	month