Clinical trials: Wound Surgical
Surgical Site Reaction
The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects
This study is being conducted to see how safe and effective the Prevena Incision Management System "Prevena" is when placed over a renal transplantation incision. Prevena provides negative pressure (suction) wound therapy.
- Trial name
- PIMS (NCT01341444)
- Testing
- Prevena Incision Management System, Standard of Care for Surgical Incisions
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- KCI USA, Inc
Trauma-related Wound, Surgical Incision
3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and Incisions
The purpose of this study is to generate safety and performance data for 3M™ Topical Tissue Adhesive. Enrolled subjects with qualifying trauma lacerations or surgical incisions will be randomized to receive 3M™ Topical Tissue…
- Conditions
- Trauma-related Wound, Surgical Incision, Surgical Wound, Laceration
- Trial name
- Lublin (NCT06217081)
- Testing
- 3M Topical Tissue Adhesive, Histoacryl® Blue Topical Skin Adhesive
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Solventum US LLC
Acute Pain
A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age < 2 years) compared to placebo…
- Trial name
- NCT01635101
- Testing
- IV Acetaminophen, IV Control
- Where
- 22 sites in United States
- Volunteers
- 197 people
- Sponsor
- Mallinckrodt
Cerebral Hemorrhage, Head Injury
Biomarkers Correlation With Volemia
The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7…
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure
- Trial name
- ENVOL (NCT01858675)
- Testing
- Biomarkers, red blood cells and plasma assessment
- Where
- France
- Volunteers
- 66 people
- Sponsor
- ThermoFisher Scientific Brahms Biomarkers France
Surgical Site Infections
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
This is a randomized, blinded, placebo and standard of care controlled study of the efficacy of a novel antibiotic containing gel compared to placebo gel in preventing surgical site infection after abdominal surgery.
- Trial name
- NCT01888367
- Testing
- DFA-02 Antibiotic Gel
- Where
- 31 sites in United States
- Volunteers
- 445 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Cataract
Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)
- Trial name
- NCT00762606
- Testing
- Phacoemulsification cataract extraction surgery, Small incision cataract surgery
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Alcon Research
C.Surgical Procedure; Dehiscence, Cesarean Section
Zip Incision Approximation vs. Suture for C-Section
The study will evaluate the ZipLine Medical Surgical Skin Closure device (Zip)versus sutures when utilized for skin layer closure during wound closure of Cesarean Section Procedure.
- Trial name
- ZIPS-C (NCT02915952)
- Testing
- Zip Surgical Skin Closure Device, Conventional Sutures
- Where
- Israel
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ZipLine Medical Inc.
Surgical Wound Infection, Traumatic Wound Infection
A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess
The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into contaminated or infected surgical or traumatic wounds or cutaneous abscess during a surgical…
- Conditions
- Surgical Wound Infection, Traumatic Wound Infection, Cutaneous Abscess
- 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.
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
Wounds and Injuries
Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies…
- Trial name
- NCT00552643
- Testing
- Suspension of polystyrene beads (POLYHEAL 1), Saline (0.9% NaCl)
- Where
- 6 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Polyheal Ltd.
Bleeding, Surgical Wound
Traumacel PULVIS and Traumacel ENDO Applicator in the Post-market Surveillance Phase
Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to prevent bleeding in the early post-operative…
- Trial name
- NCT05177887
- Testing
- Traumacel PULVIS, Traumacel ENDO Applicator
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- Bioster, a.s.
Peripheral Arterial Disease
Multi-center Study for Stent Graft System for Peripheral Artery
The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease.
- Trial name
- VJH11-01 (NCT01575808)
- Testing
- GP1101
- Where
- 15 sites in Japan
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
Dura Mater Nick Cut or Tear, Surgery
Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of…
- Trial name
- NCT02225080
- Where
- 5 sites in France, Germany and 2 more
- Volunteers
- 100 people
- Sponsor
- Integra LifeSciences Corporation
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Oncoplastic Breast Surgery, Bilateral Surgery
A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of…
- Trial name
- PICO7Y (NCT03835845)
- Testing
- PICO7Y
- Where
- 5 sites in Netherlands, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Wound Closure, Dehisced Surgical Wounds
Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
surgical adhesive systems are used to close surgical cuts and simple skin wounds. This system is a non-invasive option, meaning it can be used instead of stitches or staples.
- Trial name
- NCT07613892
- Testing
- Evaluating wound closure products to close larger surgical site incisions, Evaluating wound closure products to close smaller surgical site incisions
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Medline Industries
Tibial Fracture
Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures…
- Trial name
- NCT02820363
- Testing
- CERAMENT|G, SOC treatment
- Where
- 31 sites in United States, Germany and 2 more
- Volunteers
- 201 people
- Sponsor
- BONESUPPORT AB
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
Cataract, Astigmatism
A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with…
- Trial name
- NCT01045733
- Testing
- AcrySof IQ Toric IOL, AcrySof IQ Aspheric IOL, Limbal Relaxing Incision (LRI)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Alcon Research
Surgical Incisions
LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds
To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.
- Trial name
- NCT01835405
- Testing
- LiquiBand Flex, Dermabond Advanced, Sutures (Prolene)
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Advanced Medical Solutions Ltd.