Clinical Treatment of Acute and Chronic Wounds using Autologous Stromal Vascular Fraction Isolated from Lipoaspirate

INTERVENTION: Prospective randomized controlled study of patients from Royal Adelaide Hospital with venous ulcers on their leg. Autologous lipoaspirate will be collected from patients in groups 1 and 2 using syringe aspiration from a healthy donor site. Group 1 will have their lipoaspirate sample centrifuged in the operating theatre and subsequently injected into the wound. Group 2 will have their lipoaspirate sample processed in a sterile laboratory to isolate the SVF and subsequently injected into the wound. Group 3 will have no autologous lipoaspirate harvest or injection. The primary outcome measured will be time to complete wound closure. Aspiration and injection procedure: The procedure will be performed under local anaesthetic and sedation in an operating theatre. This will involve intravenous sedation being administered by an Anesthetist. Following this local anaesthetic will be administered by the operating surgeon. Prophylactic antibiotics will be given at the time of surgery. First the ulcer will be gently debrided to remove any debris. Following standard tumescent infiltration, autologous lipoaspirate will be harvested from the thigh or abdominal region using syringe aspiration with a 2mm diameter cannula and a 10ml syringe. A total volume of 20ml of adipose will be obtained from each patient. Group 1. The lipoaspirate sample will be centrifuged in theatre at the bedside and immediately injected in theatre. The patient will then be woken from their anaesthetic. Group 2. The lipoaspirate sample will be immediately transferred to a Class 350 laboratory (SA Pathology‐Therapeutic Products Facility, Haematology). The patient will then be woken from their anaesthetic. The SVF once processed will be injected immediately after isolation under local anaesthetic on the same day (60‐90 minutes). Injection technique For groups 1 and 2, the sample for injection will be transferred to a 1ml syringe. An 18‐gauge needle will be used for injection. The sample will be carefully deposited at the dermal‐epidermal junction at the edges of the ulcer and also directly subjacent to the wound bed. Multiple radiating passages will be made through the same insertion site to disperse the sample in different directions. Injection will only be performed on axial withdrawal of the needle. The volume of tissue grafted beneath the wound will be a function of the size of open wound and scar requiring treatment. As a rule, 1ml of sample will be injected for each 2.5cm2 area of open wound surface. Care will be taken to avoid overgrafting. All wounds will be dressed with gelonet, gauze and multilayer compression stockings. Patients will be discharged the following day. CONDITION: Chronic venous ulcer PRIMARY OUTCOME: All patients will be reviewed at weekly intervals to assess clinical progress in the Plastics outpatients clinic. A Registered Nurse who is blinded to the treatment group will perform assessment. ; Clinical photography ; Digital measurement of ulcer size using Visitrak (Smith & Nephew) ; Clinical assessment of any complications such as infection. ; ; The primary outcome measure will be ulcer healing. Ulcer healing was defined as complete re‐epithelialisation of the leg. ; SECONDARY OUTCOME: infection ‐ clinical assessment, microbiology, blood tests INCLUSION CRITERIA: ‐ Male or female, aged >18 years ‐ Venous ulceration for longer than 4 weeks between the knee and malleoli ‐ Ulcer size <10cm2 ‐ Ankle brachial pressure index of 0.85 or greater ‐ superficial or deep venous reflux on duplex scanning.