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

N

Noha Mohsen Omar

Status

Completed

Conditions

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

Treatments

Procedure: STSG
Procedure: PRP

Study type

Interventional

Funder types

Other

Identifiers

NCT03526913
1

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Male

Ages

12+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

20 participants in 2 patient groups

PRP + STSG
Experimental group
Description:
autologous PRP treatments every week prior to graft placement (STSG)
Treatment:
Procedure: PRP
Procedure: STSG
STSG Split Thickness Skin Graft
Active Comparator group
Description:
skin graft (STSG) (intervention)
Treatment:
Procedure: STSG

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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