Clinical trials: Reconstructive Surgery
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
Post-operative Pain
Effectiveness of Continuous Femoral Nerve Block Versus Single Shot Femoral Nerve Block for Pain Control
Both single shot femoral nerve block and continuous femoral nerve block with catheter have been shown to be effective for pain control after anterior cruciate ligament reconstruction (ACLR).
- Trial name
- NCT01916590
- Testing
- Bupivicaine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Colorado, Denver
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
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
Anterior Cruciate Ligament Injury
A Novel Analgesia Technique for ACL Reconstruction
A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in…
- Trial name
- NCT03292926
- Testing
- Bupivacaine, Ultrasound, Dexamethasone
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Hospital for Special Surgery, New York
Postoperative Urinary Retention, Sacrospinous Vaginal Vault Suspension
Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension
Postoperative urinary retention has been defined as the inability to void despite having fluid in the bladder during the postoperative period.
- Conditions
- Postoperative Urinary Retention, Sacrospinous Vaginal Vault Suspension, Reconstructive Pelvic Surgery
- Trial name
- NCT06258785
- Testing
- Tizanidine
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Anterior Cruciate Ligament Rupture
Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone…
- Trial name
- NCT02189317
- Testing
- Exparel
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Emory University
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Breast Cancer, Reconstructive Breast Surgery
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.
- Trial name
- NSM (NCT01796977)
- Testing
- OxyGenesys Dissolved Oxygen Dressing, Standard Gauze Dressing
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Halyard Health
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque
This study will investigate the reliability and validity of an inline 'pull-type' dynamometer for measuring peak knee extensor torque.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Trial name
- NCT05109871
- Testing
- KForce Link
- Where
- United Kingdom
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Liverpool University Hospitals NHS Foundation Trust
Breast Cancer
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with…
- Trial name
- NCT00619762
- Testing
- LTM - a porcine-based surgical mesh
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- LifeCell
Pelvic Organ Prolapse
Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery
The specific aim of this randomized double-blind placebo-controlled trial is to determine if extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic urinary tract infection (UTI) compared…
- Trial name
- NCT02727322
- Testing
- Nitrofurantoin
- Where
- 2 sites in United States
- Volunteers
- 154 people
- Sponsor
- Halina M Zyczynski, MD
Anterior Cruciate Ligament Injury
MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
This clinical trial evaluates interventions to maximize muscle function and improve cartilage health following anterior cruciate ligament reconstruction.
- Trial name
- MiACLR (NCT03626857)
- Testing
- Neuromuscular Electrical Stimulation (NMES), Eccentric Exercise (ECC)
- Where
- 2 sites in United States
- Volunteers
- 135 people
- Sponsor
- University of Michigan
Knee Injuries
Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures
The objective of this prospective study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical…
- Trial name
- NCT00418964
- Testing
- Single bundle hamstring, Double bundle hamstring, Bone patellar tendon bone
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Chinese University of Hong Kong
Anterior Cruciate Ligament Injuries
Blood Flow Restriction Training in ACL Surgery
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL)…
- Trial name
- NCT05245864
- Testing
- blood flow restriction, physical therapy standard of care
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Arkansas
Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
- Conditions
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- MINITAC (NCT04186481)
- Testing
- MINITAC Ti 2.0 suture anchor
- Where
- Australia
- Volunteers
- 32 people
- Sponsor
- Smith & Nephew, Inc.
Hypomastia, Primary Breast Augmentation
3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery
The purpose of this trial is to evaluate the impact of incorporating three-dimensional (3D)imaging during preoperative consultation on patient reported outcomes in primary breast augmentation surgery.
- Trial name
- NCT01964105
- Testing
- 3D Imaging
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Washington University School of Medicine
Breast Reconstruction, Anesthesia
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients…
- Conditions
- Breast Reconstruction, Anesthesia, Transverse Abdominis Plane Block
- Trial name
- NCT03700970
- Testing
- Liposomal bupivacaine, Regular bupivacaine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Vanderbilt University Medical Center
Patient and Surgical Related Risk Factors for Complications
TiLoop® Bra for Breast Reconstruction
A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).
- Trial name
- NCT01544023
- Volunteers
- 207 people
- Sponsor
- University of Rostock