Clinical trials: Operative Wound, open to volunteers
Dural Defect, Cerebrospinal Fluid Leak
Immiseal™ Dural Sealant Post-Market Registry Study
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct…
- Conditions
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- Trial name
- NCT07651826
- Where
- Latvia
- Volunteers
- 85 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Breast Implant Complication, Breast Implant Shell Defect
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up…
- Trial name
- NCT07810257
- Testing
- Breast Implant Exposure, Structured Implant Shell Imaging
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Breast Surgery, Regeneration
Clinical Investigation of an Ozonated Oil for the Regeneration and Healing of Surgical Wounds in Patients Undergoing Breast Surgery
This is a multicentre, prospective, randomised, double-blind, placebo-controlled clinical study designed to evaluate the regenerative and wound-healing efficacy of OZOAQUA MD OZONATED OIL in surgical wounds in patients undergoing…
- Conditions
- Breast Surgery, Regeneration, Surgical Wound Healing
- Trial name
- NCT07809308
- Testing
- ozonated oil, Non ozonated oil
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Laboratorios Ozoaqua
Diabetic Foot Ulcer, Venous Leg Ulcer
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Surgical Wound Dehiscence, Traumatic Wounds
- Trial name
- EVIDENT (NCT04920253)
- Testing
- Study Device Debridement, SOC Debridement
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Medaxis, LLC
Breast Implant Malposition, Breast Implant Rotation
Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
This prospective inception cohort will follow women for ten years after primary or revision aesthetic breast implantation. Pocket plane, incision route, implant texture, shape, volume, and operative pocket variables will be…
- Trial name
- NCT07810270
- Testing
- Aesthetic Breast Implantation, Standardized Implant Position Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Dehiscence Wound
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure.
- Trial name
- NCT04899466
- Testing
- ActiGraft
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- RedDress Ltd.
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
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
Tissue Repair, Soft Tissue Reconstruction
Urinary Bladder Matrix (UBM) Registry
The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products.
- Conditions
- Tissue Repair, Soft Tissue Reconstruction, Wound Management, Pressure Ulcer (PU)
- Trial name
- NCT07805798
- Testing
- Urinary Bladder Matrix (UBM) Products
- Volunteers
- 300 people
- Sponsor
- Integra LifeSciences Corporation
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
Ocular Trauma
Corneal Trauma Diagnostic Study
Tear fluid will be collected from patients diagnosed with ocular trauma at the University of Pittsburgh Medical Center to evaluate biomarkers.
- Trial name
- NCT07887425
- Testing
- Tear fluid collection with mass spec analysis.
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- InnSight Technology, Inc.
Surgical Wound
A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
The goal of this observational prospective study is to evaluate wound healing outcomes in resection wounds resulting from surgical removal of cutaneous malignancies treated with a synthetic electrospun fiber matrix.
- Trial name
- NCT06578650
- Testing
- Synthetic Electrospun Fiber Matrix
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Acera Surgical, Inc.
Surgical Wound, Wound
Oasis Donor Site Wounds Post-Market Study
The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom.
- Conditions
- Surgical Wound, Wound, Wounds and Injuries, Wound Heal
- Trial name
- NCT04079348
- Testing
- Oasis ECM, standard wound care
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Cook Biotech Incorporated
Breast Implant Rupture
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture
This prospective dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture.
- Trial name
- NCT07810205
- Testing
- Silicone Breast Implant Exposure, Prospective Breast Implant Surveillance Imaging
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Burn Scar, Burn Wound
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery.
- Trial name
- NCT06807021
- Testing
- IP1 control cream (Vehicle base), IP2 - 0.5% w/w FS2
- Where
- 2 sites in Canada
- Volunteers
- 70 people
- Sponsor
- Birch BioMed Inc
Rotator Cuff Tear Surgical Repair
H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery
The goal of this intent-to-treat study is to evaluate the efficacy of H-Wave Device Stimulation following rotator cuff repair surgery.
- Trial name
- NCT07501949
- Testing
- Routine post-surgical care plus H-Wave® Device Stimulation (HWDS), Routine post-surgical care
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Electronic Waveform Lab
Surgical Wound Infection, Traumatic Wound Infection
A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections
The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into infected surgical or traumatic wounds during a surgical procedure.
- Trial name
- NCT07379684
- Testing
- Amicidin-β topical solution - 15 mL, Amicidin-β topical solution - 50 mL, Standard of Care (SOC)
- Where
- 5 sites in United States
- Volunteers
- 44 people
- Sponsor
- Macro Biologics, Inc.
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar