Clinical trials: Reconstructive Surgical Procedure
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
Perfusion; Complications
The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems
This is a randomized study using a variety of techniques to compare and examine blood flow to the remaining skin after mastectomy. All treatments being used are considered standard of care and are not experimental.
- Trial name
- NCT03716050
- Testing
- Nitroglycerin, Negative Pressure Wound Therapy/ Wound VAC, Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer
Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts
The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had…
- Trial name
- NCT04534010
- Testing
- NACgraft
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Stanford University
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
Intracranial Bifurcating Aneurysms
Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms
Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.
- Trial name
- NCT02179190
- Testing
- BARREL VRD
- Where
- 3 sites in United States
- Volunteers
- 138 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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.
Ductal Carcinoma in Situ - Category, Breast Cancer
Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision.
- Conditions
- Ductal Carcinoma in Situ - Category, Breast Cancer, Prophylactic Mastectomy
- Trial name
- NASSM (NCT01969448)
- Testing
- Inframammary Fold Incision or Lateral Radial Incision, Lateral Radial Incision, Inframammary Fold Incision
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- Washington University School of Medicine
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
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
Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
- Conditions
- Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Insufficiency
- Trial name
- SGPV (NCT01092442)
- Testing
- Echocardiogram
- Where
- 8 sites in United States
- Volunteers
- 140 people
- Sponsor
- CryoLife, Inc.
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
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.
Coronary Artery Disease
Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial Single Photon Emission Computed Tomography
This protocol details a novel myocardial perfusion Single Photon Emission Computed Tomography (SPECT) protocol wherein patients receive a low-dose (6 mCi) of Tc-99m sestamibi during exercise or regadenoson pharmacologic stress…
- Trial name
- NCT01434641
- Testing
- low-dose stress MPI SPECT
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- St. Luke's-Roosevelt Hospital Center
Infection Wound, Disruption of Nerve Repair
Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
A combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. Reconstruction of these combined injuries is difficult.
- Trial name
- NCT01707654
- Testing
- Nerve flap
- Where
- China
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- The Second Hospital of Tangshan
Transversus Abdominis Plane (TAP) Block Catheter, DIEP or Free MS-TRAM Breast Reconstruction
TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT
Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients.
- Conditions
- Transversus Abdominis Plane (TAP) Block Catheter, DIEP or Free MS-TRAM Breast Reconstruction, Local Pain Management, Abdominal/ Donor Site
- Trial name
- NCT01398982
- Testing
- Bupivacaine (study group), Isotonic saline (control group)
- Where
- Canada
- Volunteers
- 93 people
- Sponsor
- University Health Network, Toronto
Postoperative Pain, Postoperative Nausea and Vomiting
Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction
Primary Objective To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment)…
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life
- Trial name
- NCT02161705
- Testing
- Ropivacaine, Saline
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Johns Hopkins University
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