Clinical trials: Reconstruction Surgery
Breast Implant; Complications, Infection or Inflammation
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal…
- Trial name
- NCT05744414
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AlloSource
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates
Scar Formation
Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery
The primary objective of this study is to assess whether intradermal injections of GBT009 along full thickness incisions following surgery results in an improvement in scar appearance.
- Trial name
- NCT01053897
- Testing
- GBT009
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Garnet BioTherapeutics, Inc.
Third-degree Burns, Reconstructive Surgery
Evaluation of NEVELIA® in Terms of Safety and Efficacy for Third-degree Burns Treatment or Reconstructive Surgery
The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery.
- Trial name
- NEVAL (NCT02089490)
- Testing
- NEVELIA® implantation
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Symatese
Tibia Fracture Non Union Bone
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a…
- Trial name
- NCT00726193
- Testing
- OsteoGen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Zimmer Biomet
Anterior Cruciate Ligament Injuries, Posterior Cruciate Ligament Tear
Interference Screw Mectascrew-C Postmarket Study
An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.
- Trial name
- NCT05791656
- Testing
- Mectascrew-C
- Where
- Switzerland
- Volunteers
- 44 people
- Sponsor
- Medacta International SA
Skin Necrosis, Breast Reconstruction
B4P Trial - BLOOM43 for Preconditioning
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer.
- Conditions
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- Trial name
- NCT07340632
- Testing
- BLOOM43
- Volunteers
- 60 people
- Sponsor
- Plexaa Ltd
ACL Reconstruction
Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a…
- Trial name
- NCT03355651
- Testing
- PROGEN
- Volunteers
- 80 people
- Sponsor
- OPKO Health, Inc.
Hip Labral Tear
Study of RNS60 on Pain and Function After Hip Labral Repair
The purpose of this study is to see if use of RNS60 during hip labral repair surgery decreases pain and improves functional capacity post-operation.
- Trial name
- NCT02005523
- Testing
- RNS60, Saline
- Where
- United States
- Sponsor
- Revalesio Corporation
Reconstructive Surgical Procedures
The SurgiMend PRS Retrospective Study
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
- Trial name
- NCT05182177
- Testing
- SurgiMend PRS
- Where
- 6 sites in Italy, Switzerland and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Plastic Surgery, Reconstructive Surgery
STARS-R Registry: Retrospective Analysis of Poly-4-hydroxybutyrate (P4HB) Scaffold Use
This is a retrospective chart review performed at multiple clinics aimed at providing real-world evidence of the use and safety of the P4HB scaffold.
- Trial name
- NCT04195854
- Testing
- P4HB product
- Where
- 10 sites in United States
- Volunteers
- 1,183 people
- Sponsor
- C. R. Bard
Flap Ischemia, Hypoxia
Spectroscopic Assessment of Tissue Oxygenation Changes in Plastic Surgical Flap Reconstructions
This study is a single-center, observational study designed to collect tissue spectrometric data.
- Trial name
- NCT07786610
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Pain, Postoperative
A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction
To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic…
- Trial name
- NCT00650598
- Testing
- valdecoxib, diclofenac
- Where
- 25 sites in Australia, Hong Kong and 7 more
- Volunteers
- 328 people
- Sponsor
- Pfizer