Clinical trials: Reconstruction Surgery
Breast Cancer
Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery
Primary Objective: To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only…
- Trial name
- NCT00542542
- Testing
- Paravertebral Block, Propofol, Fentanyl
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- M.D. Anderson Cancer Center
ACL Injury, Postoperative Pain
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following ACL reconstruction surgery. 2.
- Trial name
- NCT04246554
- Testing
- Ketorolac, Oxycodone-Acetaminophen
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Elective Reconstructive Surgery Population
The Effect of Healing Touch on Sleep
Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.
- Trial name
- Sleep7 (NCT01870076)
- Testing
- Healing Touch, Control, Presence
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Shriners Hospitals for Children
Bladder Dysfunction, Urinary Retention
Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which…
- Trial name
- NCT01460303
- Testing
- Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag, Transurethral catheter with leg bag
- Volunteers
- 49 people
- Sponsor
- University of Massachusetts, Worcester
Macromastia
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures.
- Trial name
- NCT00558246
- Testing
- Dermabond Protape (Prineo), Suture
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 79 people
- Sponsor
- Ethicon, Inc.
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Injury
Laser CO2 Versus TENS After Reconstruction of the Rotator Cuff
The purpose of this study is to evaluate the most effective method between Transcutaneous Electrical Stimulation and Light Amplification by Stimulated Emission of Radiation therapy carbon dioxide therapy for pain control in the…
- Trial name
- NCT01391000
- Testing
- LASER CO2, TENS
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Istituto Ortopedico Rizzoli
Pain, Postoperative, Pelvic Organ Prolapse
Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery
The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake…
- Trial name
- ICET (NCT03052816)
- Testing
- Ice T, Motrin/Percocet/Dilaudid for breakthrough
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Breast Cancer
Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation
The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side)…
- Trial name
- NCT02395614
- Testing
- Chlorhexidine irrigation, triple antibiotic irrigation
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Vanderbilt University Medical Center
Head and Neck Cancer, Analgesia
Multimodal Pain Study in Free Flap Patients
This study will be a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period.
- Trial name
- NCT04246697
- Testing
- Tylenol, Oxycodone, Morphine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Kansas Medical Center
Nasal Septum Perforation
Nasal Septal Flap for Donor Site Reconstruction
The purpose of this study is to demonstrate the utility of porcine small intestinal submucosa (SIS) as a graft material that may aid in the natural healing process of freshly exposed bone and cartilage in the nasal cavity.
- Trial name
- NCT03159624
- Testing
- Biodesign™ SIS graft, Doyle silastic sheet
- Volunteers
- 47 people
- Sponsor
- University of Alabama at Birmingham
Vascular Diseases, Peripheral Arterial Disease
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.
- Conditions
- Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder), Carotid Artery Diseases
- Trial name
- PHOTO-V (NCT03669042)
- Testing
- PhotoFix
- Where
- 9 sites in United States
- Volunteers
- 94 people
- Sponsor
- Artivion Inc.
Breast Reconstruction
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.
- Trial name
- NCT01256502
- Testing
- SERI® Surgical Scaffold
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Sofregen Medical, Inc.
Post Operative Pain
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery.
- Trial name
- NCT02043704
- Testing
- IV Acetaminophen
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- TriHealth Inc.
Pelvic Organ Prolapse, Surgery
Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery
To test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical reconstructive surgery.
- Conditions
- Pelvic Organ Prolapse, Surgery, Postoperative Pain
- Trial name
- NCT03040011
- Testing
- Dexamethasone, Bupivacaine, Bilateral Pudendal Nerve Block
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Lauren Giugale, MD
Coronary Disease
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
- Trial name
- RECON (NCT02073331)
- Where
- 43 sites in United States
- Volunteers
- 1,420 people
- Sponsor
- Elutia Inc.
Pain Management
Pudendal Enhancement of Enhanced Recovery After Surgery (ERAS) for Reconstructive Surgery (PEERS)
Patients will undergo their vaginal reconstructive surgery in the usual manner, but will also be randomly assigned on the day of surgery to either receive the extra injection of numbing medication at the onset of surgery or not.
- Trial name
- NCT04171050
- Testing
- Local anaesthetic, Pudendal Nerve Block plus anesthesia
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- University of California, Los Angeles
Quality of Recovery, Same Day Surgery
Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
To the investigators knowledge there are no studies in the literature evaluating the effect of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
- Conditions
- Quality of Recovery, Same Day Surgery, Nausea and Vomiting, Postoperative, Vaginal Prolapse
- Trial name
- NCT03338400
- Testing
- Dexamethasone, Normal saline
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- The Cleveland Clinic
Ischemic Reperfusion Injury, Other Reconstructive Surgery
RIPC During Free Flap With Preoperative Radiotherapy
Remote ischemic preconditioning (RIPC) has shown organ-protective effects in many clinical settings including patients with ischemic heart disease.
- Conditions
- Ischemic Reperfusion Injury, Other Reconstructive Surgery, Radiotherapy
- Trial name
- NCT03535623
- Testing
- remote ischemic preconditioning (RIPC)
- Where
- South Korea
- Volunteers
- 44 people
- Sponsor
- Seoul National University Hospital
Anterior Cruciate Ligament Tear, Knee Meniscus Tear
Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength
The purpose of this study is to compare the effects of a femoral nerve block vs. an adductor canal block on pain and quadriceps muscle strength for knee arthroscopy surgery.
- Trial name
- NCT05190120
- Testing
- Femoral Nerve Block, Adductor Canal Nerve Block, preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine
- Where
- United States
- Volunteers
- 132 people
- Sponsor
- University of California, San Francisco