Clinical trials: Reconstruction Surgery
Venous Thromboembolism, Deep Venous Thrombosis
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated…
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus, Reconstructive Surgery
- Trial name
- NCT03212365
- Testing
- Fixed dose, Variable dose
- Where
- 2 sites in United States
- Volunteers
- 295 people
- Sponsor
- University of Utah
Other Reconstructive Surgery
Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
Pedicled transverse rectus abdominus myocutaneous (TRAM) flaps are the most common post-mastectomy breast reconstructive surgeries that utilize the patient's tissue.
- Trial name
- NCT01262599
- Testing
- Ivivi Torino II PEMF Device
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Columbia University
Breast Hypertrophy, Abdominal Elastosis
Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure
Purpose: The aims of this randomized clinical trial are: 1. to assess scar quality from the patient and surgeon perspectives 2. to assess patient comfort in the days immediately following surgery 3.
- Conditions
- Breast Hypertrophy, Abdominal Elastosis, Breast Reconstruction
- Trial name
- NCT00727025
- Testing
- wound closure device (Steri-Strip™)
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Pain, Postoperative, Non-Opioid Pain Management
Virtual Reality After Breast Reconstruction Surgery
This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction.
- Conditions
- Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
- Trial name
- VR4BR (NCT03801616)
- Testing
- Virtual Reality
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Stage IA Breast Cancer, Stage IB Breast Cancer
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction.
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Trial name
- NCT02927912
- Testing
- Electron Beam Therapy, Lumpectomy, Quality-of-Life Assessment
- Where
- 5 sites in United States, Canada
- Volunteers
- 108 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
Peritoneal Surface Malignancy, Postoperative Adhesion
SurgiPerito Trial: High-Purity Type-I Collagen for Peritoneal Reconstruction After Cytoreductive Surgery
This dual-centre, randomized controlled trial evaluates the safety and efficacy of high-purity Type-I collagen-based biomaterial, as a peritoneal substitute following peritonectomy in patients undergoing cytoreductive surgery…
- Conditions
- Peritoneal Surface Malignancy, Postoperative Adhesion, Bowel Obstruction, Wound Complications
- Trial name
- NCT07241091
- Testing
- High-Purity Type-I Collagen Scaffold, Standard Peritonectomy Closure
- Where
- 2 sites in India
- Volunteers
- 60 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Third Degree Burn, Burns
StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
This pilot Phase I/II clinical study will be conducted at up to three clinical sites. This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects.
- Conditions
- Third Degree Burn, Burns, Wound Infection, Degloving Injury
- Trial name
- NCT00618839
- Testing
- StrataGraft Skin Tissue, Cadaver allograft
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Postoperative Urinary Retention
Self-discontinuation of a Transurethral Catheter
This study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (POUR), which is defined as the continued need for catheterization, following…
- Trial name
- NCT02996968
- Testing
- Self-removal
- Where
- United States
- Volunteers
- 158 people
- Sponsor
- TriHealth Inc.
Agitation, Delirium
Dexmedetomidine to Prevent Agitation After Free Flap Surgery
Reconstruction using microvascular free tissue flap has been an important management in patients with maxillofacial tumor. It is often characterised as long operation time, more traumatic and require restriction of patient's head…
- Trial name
- NCT01904760
- Testing
- Dexmedetomidine
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Peking University
A02.835.232.087.090.400.400
Effectiveness Between Two Surgical Techniques for Reconstruction of Humeral Proximal Extremity Fractures
The purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of Neer's classification.
- Trial name
- NCT02075476
- Testing
- Hemiarthroplasty, reverse arthroplasty
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Carlos Alvarez
Pain
Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine
The use of iliac crest bone graft (ICBG) remains the gold-standard in spinal reconstructive surgery for achieving fusion. Major complications from the harvesting of ICBG are rare, but chronic pain has been reported in 10-39%.
- Trial name
- NCT01087931
- Testing
- Bupivacaine, Normal Saline
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Vanderbilt University
Surgery, Breast Reconstruction
Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia technique ( interfascial block at the serratus muscle) performed in patient undergoing breast surgery and the effect of this technique on…
- Trial name
- NCT02905149
- Testing
- Serrato, Control
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Venous Thromboembolism, Deep Venous Thrombosis
Enoxaparin Metabolism in Reconstructive Surgery Patients
Venous thromboembolism (VTE) is a leading cause of death among hospitalized patients, and is an important patient safety issue in plastic surgery.
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus, Reconstructive Surgery
- Trial name
- NCT02411292
- Testing
- Enoxaparin
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- University of Utah
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
Scar
Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer
This study will test if the use of DysportTM (abobotulinumtoxinA) improves wound healing and scarring after Mohs surgery. Research in the laboratory as well as previous studies in humans have shown improved wound healing and…
- Trial name
- NCT01459666
- Testing
- Dysport (abobotulinumtoxinA), Bacteriostatic 0.9% Sodium Chloride (vehicle)
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- University Hospitals Cleveland Medical Center
Soft Tissue Support and Repair
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
- Trial name
- NCT01389232
- Testing
- SeriScaffold® Surgical Scaffold
- Where
- 5 sites in Germany, Italy and 2 more
- Volunteers
- 104 people
- Sponsor
- Sofregen Medical, Inc.
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, Perioperative/Postoperative Complications
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation.
- Trial name
- NCT01649505
- Testing
- fibrin sealant (Beriplast P, TISSEEL VH), breast reconstruction
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- OHSU Knight Cancer Institute
Pain, Postoperative
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate…
- Trial name
- NCT03383198
- Testing
- Liposomal bupivacaine right injection, Liposomal bupivacaine left injection
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Prisma Health-Upstate
Strength, Range of Motion
Low-Load Blood Flow Restriction Training vs Traditional Resistance Training Exercises Following ACLR Surgery
The main objective/s of the study is to compare the effectiveness of low load blood flow restriction training (LL-BFR) with traditional resistance training exercises (T-RT) at improving skeletal muscle hypertrophy, strength…
- Conditions
- Strength, Range of Motion, Pain-Knee, Skeletal Muscle Hypertrophy
- Trial name
- NCT06480032
- Testing
- Blood Flow Restriction band
- Where
- Pakistan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Abasyn University Peshawar