Clinical trials: Surgical Incisions
Colon Cancer, Colon Polyp
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
For patients with colon polyps (clumps of cells in the lining of the colon) treatment often requires removal of the affected portion of the colon.
- Conditions
- Colon Cancer, Colon Polyp, Diverticular Diseases, Inflammatory Bowel Diseases
- Trial name
- NCT04703829
- Testing
- VI-RASD use in minimally invasive right or left colectomy, Right or Left colectomy
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Virtual Incision Corporation
Laparotomy, Incisional Hernia
Clinical Performance and Safety of Suture-TOOL
The goal of this single arm intervention study is to investigate the safety and performance of a suturing device for closure of the midline incision after open abdominal surgery.
- Conditions
- Laparotomy, Incisional Hernia, Wound Infection, Closure Technique
- Trial name
- NCT05695157
- Testing
- Suture-TOOL
- Where
- Sweden
- Volunteers
- 38 people
- Sponsor
- Suturion AB
Wounds and Injuries, Lacerations
A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced
This was a randomized, open-label, multicenter, comparator-controlled clinical study to compare MAR-CUTIS with Dermabond Advanced in closure of surgical incisions and lacerations less than or equal to (<=)15 centimeter (cm).
- Conditions
- Wounds and Injuries, Lacerations, Surgical Incision
- Trial name
- NCT03688880
- Testing
- MAR-CUTIS, Dermabond Advanced
- Where
- 19 sites in France, Germany and 2 more
- Volunteers
- 107 people
- Sponsor
- Grünenthal GmbH
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
Cataract, Astigmatism
Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)
This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts.
- Trial name
- ARCUATAS (NCT05053620)
- Testing
- Calculation of the arcuate intrasomal incisions
- Where
- Spain
- Volunteers
- 22 people
- Sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Post Surgical Incisions From Abdominoplasty Procedures
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.
- Trial name
- Mona Lisa (NCT00766727)
- Testing
- GLYDe Dressing
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neodyne Biosciences, Inc.
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
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.
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
Post-surgical Wounds
Evaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds
This is a prospective randomized controlled case series in patients having a surgery for bilateral breast reduction. Objectives of the case series are to evaluate the safety and efficacy of the FBPM10 System when compared with…
- Trial name
- NCT03271164
- Testing
- FBPM10 System, Massages with vitamin E cream
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- KLOX Technologies Inc.
Laparotomy, Suture; Complications, Mechanical
DuraMesh Laparotomy Study
This is a multisite randomized control proof-of-concept trial to evaluate the safety of Duramesh laparotomy closure in the trauma and emergency laparotomy setting.
- Conditions
- Laparotomy, Suture; Complications, Mechanical, Hernia Incisional
- Trial name
- NCT03966768
- Testing
- Duramesh suturable mesh for laparotomy closure, Conventional suture for laparotomy closure
- Sponsor
- Mesh Suture Inc.
Surgical Site Infection, Sternal Infection
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic…
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Trial name
- NCT03558984
- Testing
- D-PLEX, Standard of Care
- Where
- 3 sites in United States, Israel
- Volunteers
- 2 people
- Sponsor
- PolyPid Ltd.
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.
Infection, Surgical Site Infection
Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in Chinese…
- Trial name
- NCT01254344
- Testing
- ertapenem sodium, ceftriaxone sodium, metronidazole
- Volunteers
- 599 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Hernia, Surgical Wound Dehiscence
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive…
- Trial name
- StAR (NCT01083472)
- Testing
- Strattice(TM) Reconstructive Tissue Matrix, Suture/suture with absorbable mesh
- Where
- 29 sites in France, Germany and 4 more
- Volunteers
- 37 people
- Sponsor
- LifeCell
Pressure Ulcer, Arterial Ulcers
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected…
- Conditions
- Pressure Ulcer, Arterial Ulcers, Venous Leg Ulcer, Diabetic Ulcers
- Trial name
- NCT05646121
- Testing
- Suprasorb® A + Ag wound dressing and rope
- Where
- 8 sites in Poland
- Volunteers
- 99 people
- Sponsor
- Lohmann & Rauscher
Surgical Site Infection
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
- Trial name
- NCT02255487
- Testing
- IrriSept System, No Intervention - Standard of Care (SoC) only
- Where
- 17 sites in United States
- Volunteers
- 627 people
- Sponsor
- Irrimax Corporation
Surgical Site Infection
DFA-02 in Patients Undergoing Colorectal Surgery
This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and…
- Trial name
- NCT01496352
- Testing
- DFA-02
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Dr. Reddy's Laboratories Limited