Clinical trials: Reconstructive Surgery
Breast Cancer
Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial
A 2 arm, 90 patient (45 per cohort) trial in patients with breast cancer who will be undergoing mastectomy with immediate tissue-expander reconstruction to determine whether treatment with zafirlukast (20mg PO BID) can reduce or…
- Trial name
- NCT02950480
- Testing
- zafirlukast, Standard of Care (no intervention)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, San Francisco
Breast Cancer
Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction
Subjects are being asked to participate in this study because they will be undergoing unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction involving insertion of a tissue expander.
- Trial name
- NCT02525718
- Testing
- Saline, 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Northwestern University
Coagulopathic Bleeding
Open Label Use Of RiaStap During Aortic Reconstruction
The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product…
- Trial name
- NCT01300286
- Testing
- RiaSTAP
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Duke University
Trauma
Investigating Outcomes of Lower Limb Trauma
This is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. This will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb…
- Trial name
- NCT01691950
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Pain, Postoperative
Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management
Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.
- Trial name
- NCT04284930
- Testing
- Depobupivacaine, OnQ pump, 0.25% Bupivacaine
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- The Cleveland Clinic
Catheter-Associated Urinary Tract Infection
Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients
The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal.
- Trial name
- PRECAUTION (NCT01108757)
- Testing
- Bactrim
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Hernia, Abdominal, Abdominal Injuries
ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects
- Trial name
- ENHANCE (NCT01268514)
- Where
- 12 sites in Belgium, Germany and 3 more
- Volunteers
- 115 people
- Sponsor
- Medtronic - MITG
Post Operative Pain
The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction
The purpose of this research study is to investigate whether or not platelet rich plasma (PRP) may help to improve tendon healing and decrease post operative pain in patients undergoing anterior cruciate ligament (ACL)…
- Trial name
- NCT01765712
- Testing
- Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft, Platelet Rich Plasma
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Brian Walters
Heart Defects, Congenital
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on…
- Trial name
- NCT00115934
- Testing
- Blalock-Taussig pulmonary artery shunt, Right ventricular to pulmonary artery shunt
- Where
- 13 sites in United States, Canada
- Volunteers
- 555 people
- Sponsor
- Carelon Research
Breast Cancer
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking.
- Trial name
- NCT03346161
- Testing
- Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction", Decision tool, Usual Care Group - Outcome Measures
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Washington University School of Medicine
Breast - Female
Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
The primary objective is to determine if pre-operative transversus abdominis plane (TAP) nerve blocks by continued infusion of local anesthetic post-operatively affects post-operative narcotic usage, as compared to a placebo TAP…
- Trial name
- NCT02601027
- Testing
- Transversus Abdominis Plane (TAP) block, Nimbus Infusion Pump IV Administration, Bupivacaine infusion
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Stanford University
Cancer
App-Assisted Day Reconstruction to Reduce Logistic Toxicity in Cancer
The number of new cases of cancer diagnosed in the U.S. was 1.7 million in 2017 and is expected to increase by 35% to 2.3 million in 2030[1].
- Trial name
- NCT05502302
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Breast Cancer, Postoperative Pain
Liposomal Bupivacaine in Implant Based Breast Reconstruction
Objectives: 1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels. 2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events. 3.
- Trial name
- NCT02659501
- Testing
- Liposomal bupivacaine, Bupivacaine with epinephrine, Morphine sulfate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Loma Linda University
Narcotic Consumption, Pain
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures
This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice.
- Conditions
- Narcotic Consumption, Pain, Wound Healing, Patient Satisfaction
- Trial name
- NCT00950183
- Testing
- Iceman® Cold Therapy unit (djOrtho), Ice
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- OrthoCarolina Research Institute, Inc.
Pain, Postoperative, Mammaplasty
Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken.
- Trial name
- NCT04278846
- Testing
- Depofoam bupivacaine, Bupivacaine hydrochloride (HCl)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- The Cleveland Clinic
Hernia Repair With Compartment Syndrome
Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.
- Trial name
- Flex HD (NCT01597128)
- Testing
- Flex HD, Strattice
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- John Roth
Adult Spinal Deformity
Tranexamic Acid Dosing in Adult Spinal Deformity Surgery
The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.
- Trial name
- NCT02053363
- Testing
- Tranexamic Acid (Cyklokapron)
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Washington University School of Medicine
Venous Thromboembolism
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in VTE events despite…
- Trial name
- NCT04504318
- Testing
- Apixaban 2.5 MG Oral Tablet, Enoxaparin 40Mg/0.4mL Prefilled Syringe
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Stanford University
Burns
Comparison of Skin Substitutes Used in Burn Care
The purpose of this study is to determine if using a DERMAL LAYER under skin grafts: 1. will reduce scar formation of skin grafts 2. will reduce burn wound contractures 3.
- Trial name
- Quad (NCT00676013)
- Testing
- Integra, AlloDerm, Homograft
- Where
- 2 sites in United States
- Volunteers
- 158 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Breast Cancer
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast…
- Trial name
- NCT01823107
- Testing
- Meso BioMatrix Device
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Kensey Nash Corporation