Clinical trials: Wounds, Closure
Surgical Wound
VASCADE ANTEGRADE-PVD Post-Market Registry
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional…
- Trial name
- NCT02948257
- Testing
- Cardiva Medical VASCADE VCS
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cardiva Medical, Inc.
Wounds
Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)
The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.
- Trial name
- BSG-12 (NCT01807650)
- Testing
- Oleogel-S10, non-adhesive wound dressing, Non-adhesive wound dressing only
- Where
- 14 sites in France, Greece and 2 more
- Volunteers
- 112 people
- Sponsor
- Birken AG
Wounds
Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)
The main purpose of this phase III clinical trial was to compare intra-individually the efficacy, safety and tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only in accelerating the…
- Trial name
- NCT01657305
- Testing
- Oleogel-S10, non-adhesive wound dressing, Non-adhesive wound dressing only
- Where
- 24 sites in Austria, Bulgaria and 4 more
- Volunteers
- 107 people
- Sponsor
- Birken AG
Lacerations
Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department.
- Trial name
- NCT00547638
- Testing
- cyanoacrylate with pressure sensitive mesh, cyanoacrylate
- Where
- 9 sites in United States
- Volunteers
- 216 people
- Sponsor
- Ethicon, Inc.
Surgical Wound
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites.
- Trial name
- RESPECT (NCT01297322)
- Testing
- Manual compression, Cardiva VASCADE™ Vascular Closure System
- Where
- 21 sites in United States, Australia
- Volunteers
- 420 people
- Sponsor
- Cardiva Medical, Inc.
Bankart Lesion, Acetabular Labrum Tear
S&P of Q-Fix™ All-Suture Anchor System
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
- Conditions
- Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain
- Trial name
- NCT03594071
- Testing
- The Q-Fix™ All-Suture Anchor
- Where
- 5 sites in United States
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, 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
Traumatic Lacerations or Surgical Incisions
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in terms of cosmesis (appearance) of the repaired wound when these devices are used for closure of surgical and traumatic wounds .
- Trial name
- NCT01716013
- Testing
- BondEase, CWCD
- Where
- 6 sites in United States
- Volunteers
- 162 people
- Sponsor
- OptMed, Inc.
Surgical Wound
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
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 at the completion of catheter-based procedures…
- Trial name
- NCT03573206
- Testing
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Cardiva Medical, Inc.
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.
Burns
Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.
- Trial name
- NCT01657292
- Testing
- Oleogel-S10 ointment, Octenilin® wound gel
- Where
- 9 sites in Germany, Sweden and 2 more
- Volunteers
- 61 people
- Sponsor
- Birken AG
Surgical Incisions
Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions.
- Trial name
- NCT00557947
- Testing
- Suture, Dermabond Protape (Prineo)
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Surgical Wound
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
- Trial name
- Closer (NCT02136004)
- Testing
- Closer VSS
- Where
- 12 sites in United States
- Volunteers
- 220 people
- Sponsor
- Rex Medical
Surgical Wound Dehiscence
Trial of Versajet Compared With Conventional Treatment in Acute and Chronic Wounds
It is increasingly recognised that the debridement of devitalised, bacterially contaminated or senescent tissue is an essential component of the effective treatment of delayed healing wounds.
- Trial name
- NCT01050673
- Testing
- VERSAJET, Scalpel or blade
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
CSF Leak
The Paediatric EVICEL® Neuro Study
The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for suture-line sealing in dura-mater closure in elective or urgent paediatric cranial neurosurgery to provide intraoperative watertight…
- Trial name
- NCT02309645
- Testing
- EVICEL® Fibrin Sealant, Sutures Only
- Where
- 7 sites in United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, 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
Post-operative Complications, Surgical Site Infection
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
- Conditions
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- Trial name
- NCT01450631
- Testing
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- KCI USA, Inc