Clinical trials: Burn Surgery
Donor Site Complication
An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients
The investigator will identify the test donor site and test location will be considered on the upper anterior thighs as being the most suitable if available. Circumferential donors will be considered acceptable as well.
- Trial name
- NCT01670201
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer, Venous Leg Ulcer
PLASOMA Ultimate Safety & Efficacy Study
The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound
- Trial name
- PULSE (NCT04828304)
- Testing
- PLASOMA
- Where
- 6 sites in Netherlands
- Volunteers
- 101 people
- Sponsor
- Plasmacure
Burn Surgery
Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery
The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery.
- Trial name
- NCT00974597
- Testing
- AWBAT™-D and Mepilex® Ag dressings
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Aubrey Inc.
Critical Illness, Burns
Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.
- Conditions
- Critical Illness, Burns, Surgery, Urinary Tract Infections
- Trial name
- CAB (NCT03816384)
- Testing
- Standard of Care, DLC Group, DLCS Group
- Sponsor
- Potrero Medical
Hematologic Neoplasms, Burns
Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital
The overall objective of this study is to collect preliminary safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with burns and patients with hematological malignancies.
- Trial name
- NCT05549232
- Testing
- Hypoxic Red Blood Cells
- Where
- Norway
- Volunteers
- 22 people
- Sponsor
- Hemanext
Skin Scars, Post-burn Scars
Exploratory Study to Evaluate the Efficacy of the Cosmetic Product RV3895A on Re-epidermised Scars Following Burns and Surgical Stitches in Adults, Adolescents and Children Over a 6-month Follow-up Period
This study is exploratory, non-comparative and open-label, conducted in France. It aims to provide insights into the effectiveness and safety of RV3895A - RY1774, potentially benefiting participants by improving scar appearance…
- Conditions
- Skin Scars, Post-burn Scars, Post-surgical-stitches Scars
- Trial name
- NCT07020507
- Testing
- Product gel RV3895A
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Pierre Fabre Dermo Cosmetique
Diabetic Ulcers, Venous Leg Ulcer
PMCF Study of Debridement Pad
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by…
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer
- Trial name
- NCT07255937
- Testing
- Debridement Pad
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- Advanced Medical Solutions Ltd.
Surgical Wound, Trauma Wound
Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds
The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound.
- Conditions
- Surgical Wound, Trauma Wound, Autografts, Partial-thickness Burn
- Trial name
- NCT06750809
- Testing
- PermeaDerm Biosynthetic Wound Matrix, Frozen Human Cadaveric Allograft (FHCA)
- Where
- 13 sites in United States
- Volunteers
- 40 people
- Sponsor
- Avita Medical
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
Surgical Hemostasis
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.
- Trial name
- NCT00371215
- Testing
- rThrombin
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- ZymoGenetics
Cutaneous Ulcer, Diabetic Ulcer
Dermacyte® Liquid for Treatment of Cutaneous Ulcers and Wounds
The objective of this study is to make Dermacyte Liquid available on an expanded access basis to treat cutaneous ulcers and wounds refractory to initial treatment or that do not have adequate alternative treatments.
- Conditions
- Cutaneous Ulcer, Diabetic Ulcer, Surgical Wound Dehiscence, Burns - Multiple
- Trial name
- NCT06730022
- Testing
- MTX-001 (Dermacyte Liquid)
- Where
- United States
- Sponsor
- Merakris Therapeutics
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
Split-thickness Skin Graft Donor Sites
Clinical Study on Veloderm for the Treatment of Split-thickness Skin Graft Donor Sites
This study is a multi-center, randomized, open and paralleled positive control study for evaluating the safety and efficacy of Veloderm in treatment of split-thickness skin graft donor sites.
- Trial name
- NCT01512017
- Testing
- Crystalline cellulose simple occlusive dressing, Vaseline
- Volunteers
- 96 people
- Sponsor
- Lee's Pharmaceutical Limited
Post Surgical Scars, Epidermic Burn
Cicatrix Cream in Post Surgical Scars and Epidermic Burn
The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of epidermic burns or post surgical scars. The duration of this phase 2 clinical trial will be two months.
- Trial name
- NCT01018589
- Testing
- Cicatrix cream
- Where
- Cuba
- Volunteers
- 100 people
- Sponsor
- Catalysis SL
Treatment of Donor Site Burns
Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery
The purpose of this study is to compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment.
- Trial name
- AWBAT-D (NCT00964470)
- Testing
- AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Aubrey Inc.
Third-degree Burns, Reconstructive Surgery
Evaluation of NEVELIA® in Terms of Safety and Efficacy for Third-degree Burns Treatment or Reconstructive Surgery
The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery.
- Trial name
- NEVAL (NCT02089490)
- Testing
- NEVELIA® implantation
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Symatese
Wounds and Injuries, Burns
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed
- Trial name
- SIDDX (NCT06328010)
- Testing
- Various types of wound care treatments
- Where
- 12 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Siddhey LLC
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Leg Ulcer, Diabetic Foot Ulcer
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound
- Trial name
- GELFI (NCT05148390)
- Testing
- Cutimed® Gelling Fiber
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- BSN Medical 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