Clinical trials: Surgical Wounds
Laceration of Skin, Injury Skin
Assessment of DAFILON® Suture Material for Skin Closure
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon®) will be evaluated for skin closure in adult and pediatric patients.
- Trial name
- SKINDA (NCT04617041)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 115 people
- Sponsor
- Aesculap AG
Capsular Contracture of Breast Implant
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Clinically Significant Capsular Contracture
This prospective breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture.
- Trial name
- NCT07810231
- Testing
- Breast Implant Exposure, Standardized Capsular Contracture Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Arthroplasty, Replacement, Knee
ZIPS Study - Zip Incision Approximation vs. STAPLE
Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.
- Trial name
- ZIPS (NCT02255877)
- Testing
- Zip Surgical Skin Closure, Steel Staples
- Where
- United States
- Sponsor
- ZipLine Medical Inc.
Surgical Wound, Herniation
Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy
To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.
- Trial name
- NCT03536013
- Testing
- Other: Full-thickness placental allograft
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- StimLabs
Surgical Site Occurences After Sternotomy, Wound Infection
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy).
- Trial name
- NCT02195310
- Testing
- Prevena™ Incision Management System, Conventional sterile wound dressings
- Where
- 13 sites in Austria, Germany and 1 more
- Volunteers
- 342 people
- Sponsor
- Solventum US LLC
Burn, Trauma Wound
Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds
The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds.
- Conditions
- Burn, Trauma Wound, Full Thickness Wounds, Surgical Wound
- Trial name
- Cohealyx I (NCT06787690)
- Testing
- Cohealyx
- Where
- 18 sites in United States
- Volunteers
- 41 people
- Sponsor
- Avita Medical
Macromastia
PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following…
- Trial name
- PRECISE (NCT00986453)
- Testing
- PEAK PlasmaBlade, Traditional Electrosurgery with scalpel
- Where
- 7 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
Gluteal Tissue Ischemia Risk, Foreign-Body Reaction
Prospective Agreement Study of Magnetic Resonance Imaging Measurements and Intraoperative Dimensions During Gluteal Permanent Synthetic Filler Removal
This prospective agreement study will compare preoperative MRI measurements with direct surgical measurements in adults undergoing removal of gluteal tissue affected by permanent synthetic fillers.
- Conditions
- Gluteal Tissue Ischemia Risk, Foreign-Body Reaction, Soft Tissue Filler Complication
- Trial name
- NCT07808996
- Testing
- Preoperative MRI Morphometric Mapping, Standardized Intraoperative and Fresh-Specimen Measurement
- Volunteers
- 220 people
- Sponsor
- Research Inc
Diabetic Foot Ulcer, Chronic Ulcers of the Lower Limb
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers.
- Trial name
- NCT07444593
- Testing
- Biodynamik XT3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Biodynamik, Inc
Defect of Articular Cartilage, Articular Cartilage Disorder of Knee
the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee
The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.
- Conditions
- Defect of Articular Cartilage, Articular Cartilage Disorder of Knee, Degeneration; Articular Cartilage, Knee
- Trial name
- NCT02524509
- Where
- South Korea
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Trauma Injury, Maxilla Fracture
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK/MICROTEK®) used for…
- Conditions
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- Trial name
- NCT05742932
- Testing
- Trauma surgery using Global D's implants.
- Where
- 2 sites in France
- Volunteers
- 99 people
- Sponsor
- Global D
Tendon Injuries, Tendinopathy
NuShield in Surgical Peroneal Tendon Repair
The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical tendon repair.
- Trial name
- NCT03828916
- Testing
- NuShield
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- NuTech Medical, Inc
Scar, Incision
A Safety and Efficacy Study to Evaluate AIV001 in Wound Healing Following Surgical Incision
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds
- Conditions
- Scar, Incision, Abdominal, Wound (Morphologic Abnormality)
- Trial name
- NCT03639883
- Testing
- AIV001
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AiViva BioPharma, Inc.
Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection
Surgicel NU-KNIT Vs Bone Wax on Median Sternotomy
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier.
- Trial name
- NBCS (NCT06869772)
- Testing
- Closure of sternotomy
- Where
- Qatar
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
Postoperative Wound Infection-deep, Post Operative Wound Infection
A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60
This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to sterile saline (Group B) in adult subjects…
- Trial name
- NCT02280395
- Testing
- RUT058-60, Sterile saline for irrigation
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Pulmatrix Inc.
Ankyloglossia
Case Series of Infants With Anterior Ankyloglossia Being Treated by the Sublingual Neonatal Incision Platform Device
A study assessing the feasibility of a novel device designed specifically to treat infant tongue-tie.
- Trial name
- SNIP (NCT07655895)
- Testing
- Frenectomy of anterior ankylogossia using the novel device
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Europa Life Sciences Limited
Mastectomy
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy
The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and…
- Trial name
- PRECISE (NCT00943605)
- Testing
- Scalpel and Traditional Electrosurgery, PEAK PlasmaBlade
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Surgical Technologies
Macromastia
A Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged…
- Trial name
- PRECISE (NCT01284491)
- Testing
- PEAK PlasmaBlade 4.0, Traditional Electrosurgery with scalpel
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medtronic Surgical Technologies
Scar Prevention
Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
- Trial name
- NCT01038297
- Testing
- EXC 001
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Postoperative Pain, Postoperative Edema
Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use
The goal of this observational registry study is to characterize postoperative recovery outcomes in adult patients receiving standard-of-care perioperative light therapy using an FDA-cleared photobiomodulation device as part of…
- Conditions
- Postoperative Pain, Postoperative Edema, Postoperative Ecchymosis, Surgical Wound Healing
- Trial name
- NCT07311889
- Testing
- Perioperative photobiomodulation light therapy
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Elixir MD Inc