Clinical trial NCT03526913: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Menoufia University
First posted: 2018-05-16
Enrollment: 20
Sex: MALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Graft take
timeFrame: month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Menoufia University
name: Sherif M. Elkashty, PHD
role: PRINCIPAL_INVESTIGATOR
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