Clinical trials: Incision
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.
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
Stress Urinary Incontinence
Desara ® One Single Incision Sling 522 Study
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
- Trial name
- NCT04772131
- Testing
- Desara® One Single Incision Sling, Desara® Blue Transobturator Sling
- Where
- 15 sites in United States
- Volunteers
- 300 people
- Sponsor
- Caldera Medical, Inc.
Endophthalmitis
OTX-14-002: Device Exposure Registry
The objective of the study is to collect post-approval data relative to the incidence of endophthalmitis for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under…
- Trial name
- NCT02309736
- Testing
- ReSure Sealant
- Sponsor
- Ocular Therapeutix, Inc.
Cataracts
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery
The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.
- Trial name
- NCT01383057
- Testing
- Femtosecond Laser
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Innovative Medical
Hernia
Repair of Infected or Contaminated Hernias
This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites.
- Trial name
- RICH (NCT00617357)
- Testing
- LTM (Strattice Reconstructive Tissue Matrix)
- Where
- 15 sites in United States
- Volunteers
- 83 people
- Sponsor
- LifeCell
Scarring
Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions
The purpose of this study is to assess the safety and local tolerability of two different concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a day for 21 days to artificially induced dermal…
- Trial name
- NCT03036306
- Testing
- SCX-001
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ScarX Corp
Ventral Hernias, Incisional Hernias
Antimicrobial Hernia Repair Device
This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in…
- Trial name
- NCT02730936
- Testing
- Antimicrobial Hernia Repair Device
- Sponsor
- Cook Group Incorporated
Surgical Site Infection
Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle
ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties.
- Trial name
- NCT02578771
- Testing
- ZuraPrep with 70% IPA, ZuraPrep without 70% IPA, ChloraPrep CHG/IPA Teal Tint
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Zurex Pharma, Inc.
Hypermetropia
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia
The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.
- Trial name
- V1601CI (NCT03431571)
- Testing
- ReLEx SMILE
- Where
- 8 sites in China, Czechia and 4 more
- Volunteers
- 374 people, healthy volunteers welcome
- Sponsor
- Carl Zeiss Meditec AG
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Surgical Wound
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA)…
- Trial name
- NCT03193021
- Testing
- Cardiva Mid-Bore VVCS, Manual compression
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Cardiva Medical, Inc.
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
Ventral Hernia, Incisional Hernia
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.
- Trial name
- NCT01961687
- Testing
- Resorbable Mesh
- Where
- 16 sites in United States
- Volunteers
- 121 people
- Sponsor
- C. R. Bard
Surgical Wounds
Evaluation of the KLOX BioPhotonic WoundGel System in the Treatment of Surgical Wounds
This is a multicenter, randomized, prospective, controlled study in patients having bilateral breast reduction. Objectives of the study are to evaluate the safety and efficacy of the KLOX BioPhotonic WoundGel System compared with…
- Trial name
- NCT02604251
- Testing
- KLOX BioPhotonic WoundGel System, Silicone sheets
- Where
- 2 sites in Canada
- Volunteers
- 42 people
- Sponsor
- KLOX Technologies Inc.
Cataracts
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.
- Trial name
- NCT01298973
- Testing
- Viscoat, Saline
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Innovative Medical
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
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
Wound Heal
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs…
- Trial name
- MOSAIC (NCT06600152)
- Testing
- MAP Wound Matrix, DuoDerm
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tempo Therapeutics
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher