Extremity wounds with exposed critical structures, including bone and tendon are a major
burden on the American healthcare system with limited treatment options. Free Flap
reconstructions of lower extremity wounds have an increased failure rate in comparison to
elective free flap procedures.These procedures are long and are associated with a high cost
of care, prolonged hospital stays, and are limited by the need for surgical specialist
availability and patient vessels suitable for anastomoses. This study will use a new
treatment modality which is a commercially ready human amniotic membrane allograft (EpiFix)
to promote a granulation tissue wound base that will be suitable for skin grafting, thus
forgoing the need for a flap-based for reconstruction. The study goals are to reduce the
overall cost of providing definitive treatment by decreasing operative time, length of
hospital stay, decrease the need for intensive nursing care and rehabilitation. This study
will aim to provide a treatment option that is readily accessible to all patients with these
complex wounds in any healthcare setting across the country.
Clinical Trials
Clinical Trial – intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain
this study investigates the analgesic efficacy and other possible effects of ketamine,
morphine, and both together when administered intrathecally for control of postoperative pain
following lower abdominal cancer surgeries.
Clinical Trial – Hyperbaric Oxygen Therapy for Renal Regeneration in Diabetic Nephropathy
Diabetes kidney disease is a leading cause for end stage renal disease in the western world.
To date no treatment that can reverse renal damage exists.
Chronic hypoxia is one of the major key insults affecting the diabetic kidney, and many of
the new treatments under study focus on it’s consequences, but no treatment can improve the
hypoxia as both increased renal perfusion and decreased renal perfusion may be associated
with it’s worsening. Hyperbaric oxygen therapy (HBOT) can improve renal hypoxia by increasing
partial pressure of dissolved (non-hemoglobin-bound) oxygen without affecting it’s demand.
HBOT also recruits tissue and peripheral progenitors and supplies the optimal environment
crucial for their proliferation and for tissue repair. Hyperbaric oxygen treatment was known
for years as an effective treatment for diabetic ulcers. Recent trials have shown great
impact on brain lesions (in diabetic and non-diabetic patients) it is now the time to
evaluate the effect of HBOT on the diabetic kidney.
Clinical Trial – Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section
Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect
the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric
bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher
cardiac output than those who received phenylephrine
Clinical Trial – The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section
The primary endpoint of this study is to investigate the effect of adding nalbuphine to
intrathecal morphine on quality of postoperative analgesia and Morphine related side effects
post- cesarean delivery.
Clinical Trial – Continuous Infusion for Pain Relief
SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice
to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative
analgesia. high incidence of side effects was noted. is there any alternative?
Clinical Trial – Comparison of Combined Sciatic(Winnie’s) Femoral Nerve Block, and Subarachnoid Block Anesthesia for Lower Limb Surgery
60 ASA grades- I, II or III patients, undergoing lower limb surgeries, will be randomly
allocated in 2 groups of 30 patients each. In group S- subarachnoid block with 0.5%
Bupivacaine (hyperbaric) 2.5ml will be given in lateral position and group B received femoral
3 in 1 block in supine position(with landmark technique) with 20 ml of 0.25% of Bupivacaine,
followed by Sciatic block in lateral position with 20 ml of 0.25% Bupivacaine. Onset and
duration of sensory and motor block, time of first analgesic requirement, VAS Scores at end
of block and surgery, hemodynamic effects, patients’ and surgeon’s satisfaction will be
evaluated.
Clinical Trial – Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy
Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic
resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery
(GKS) by treatment with hyperbaric oxygen therapy (HBO)
Clinical Trial – Quality of Recovery After General or Spinal Anesthesia for Inguinal Hernia Repair
Different anesthetic techniques have been proposed for carrying out Inguinal hernia repair,
including local anesthesia, regional and general. There are no recent data on the application
of a validated questionnaire to assess which anesthetic technique, local infiltration under
general anesthesia or spinal anesthesia, would provide better quality of recovery in the
opinion of the patients undergoing inguinal hernia repair. The aim of the study is to perform
a randomized clinical trial comparing the quality of recovery (QoR-40) after local
infiltration under general anesthesia via laryngeal mask (LMA) or spinal anesthesia for
unilateral inguinal hernia repair. METHODS – Seventy patients aged 18 to 65 years old, who
were scheduled to undergo unilateral inguinal hernia repair at Santa Lucinda Hospital will be
enrolled in the study. The anesthesia will be performed according to the following sequence:
L Group – intravenous (I.V.) propofol and alfentanyl, followed by LMA positioning. The
anesthesia will be maintained by propofol. For local anesthesia, approximately 50 ml of 0.5%
ropivacaine will be infiltrated along the line of incision in the subcutaneous plane,
followed by peripheral nerve block technique (e.g., ilioinguinal-hypogastric nerve block) and
local wound infiltration at the fascial level. S Group – spinal puncture followed by
intrathecal 15 mg of 0.5% hyperbaric bupivacaine injection and sedation with propofol by
continuous infusion. Pain will be assessed every 15 minutes at Post-anesthesia Care Unit
(PACU) using a 0-10 numeric pain rating scale and I.V. morphine will be administered to
maintain the pain score below 4. The QoR-40 will be administered by a blind investigator 24
hours after surgery.
Clinical Trial – Fascia Iliaca Compartment Block for Proximal-end Femur Fractures
Fracture femur is a common injury which is associated with excruciating pain. Positioning for
neuraxial blocks is always challenging because even slight overriding of the fracture ends is
intensely painful .It can causing major patient distress which accompanied by well-known
physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and
increased cardiac work that may compromise high-risk cardiac patients.
Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of
the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but
it is also associated with minimal risk as the local anesthetic is injected at a safe
distance from the femoral artery and femoral nerve. It is always safe to perform the fascia
iliaca compartment block prior to spinal anesthesia as the patient can respond during
administration of the local anesthetic and can prevent intra-neuronal injections