Clinical trials: Skin Grafting
Biliary Tract Neoplasms, Pancreatic Neoplasms
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive…
- Conditions
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
- Trial name
- NCT00196105
- Testing
- 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent, 10 mm Stainless Steel Wallstent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Cook Group Incorporated
Chronic Spontaneous Urticaria
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201
- Trial name
- NCT02649218
- Testing
- Ligelizumab
- Where
- 67 sites in United States, Australia and 8 more
- Volunteers
- 226 people
- Sponsor
- Novartis Pharmaceuticals
Burns
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.
- Trial name
- NCT03229564
- Testing
- EHSG-KF, STSG
- Where
- 4 sites in Italy, Netherlands and 1 more
- Volunteers
- 12 people
- Sponsor
- CUTISS AG
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
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
Breast Neoplasms, Carcinoma, Ductal, Breast
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty, Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
- Trial name
- RESTORE-2 (NCT00616135)
- Testing
- ADRC-Enhanced Autologous Fat Transplant
- Where
- 5 sites in Belgium, Italy and 2 more
- Volunteers
- 71 people
- Sponsor
- Cytori Therapeutics
Wound Heal
Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function
- Trial name
- NCT04829331
- Testing
- Restrata
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Acera Surgical, Inc.
Leg Ulcer, Varicose Ulcer
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
- Trial name
- NCT00399308
- Testing
- Celaderm (Frozen Cultured Epidermal Allograft), Control (compression bandaging)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Shire
Diabetic Foot Ulcer
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers
- Trial name
- NCT07039396
- Testing
- NeoThelium FT (HCT/P 361)
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- NuScience Medical Biologics, LLC
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Foot Ulcer, Diabetic
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety.
- Trial name
- NCT05586542
- Testing
- DERMASEAL, Plasma Film, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- Vitruvian Medical Devices, Inc.
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
Metastatic Breast Cancer in the Spine
ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES
ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine…
- Trial name
- ZGMBC (NCT05280067)
- Testing
- ZetaMet™ (ZetaFuse™ Bone Graft)
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- Zetagen Therapeutics, Inc
Acute Wounds
Safety and Performance of SoftOx Wound Irrigation Solution (SWIS) in Acute Wounds
This pilot study evaluates safety and performance of the Medical device, SoftOx Wound Irrigation Solution (SWIS), in a model for acute wounds.
- Trial name
- SWIS-01 (NCT03742284)
- Testing
- SoftOx Wound Irrigation Solution
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- SoftOx Solutions AS
Surgery-Complications
Kerecis Case Registry for SurgiBind : Soft Tissue Reinforcement
Registry Objectives The overall objective of the registry is to collect quality and safety data to assess the long-term outcomes of Kerecis Omega3 SurgiBind in surgical procedures to reinforce soft tissue and prevent surgical…
- Trial name
- NCT05898711
- Testing
- Fish skin graft
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Kerecis Ltd.
Burns
Safety and Efficacy of I-020502 in Meshed Skin Autografting
This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to…
- Trial name
- NCT00471939
- Testing
- I-020502
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Kuros Biosurgery AG
Diabetic Foot Ulcer
Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers
This is a 2 part study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on chronic diabetic foot ulcers (DFU). Nitric oxide has a range of effects on the body including vasodilation and angiogenesis.
- Trial name
- ProNOx1 (NCT01982565)
- Testing
- NOx dressing, Standard of Care
- Where
- 10 sites in United Kingdom
- Volunteers
- 130 people
- Sponsor
- Edixomed Ltd
Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in…
- Trial name
- NCT06681428
- Testing
- Allograft
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- Tides Medical
Actinic Keratosis
A Study to Evaluate the Effectiveness and Safety of Multiple Applications of Imiquimod 5% Cream for the Treatment of Actinic Keratoses in Organ Transplant Recipients
The purpose of the study is to compare effectiveness and safety of multiple applications of imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.
- Trial name
- NCT00189267
- Testing
- Imiquimod 5 % Cream
- Volunteers
- 45 people
- Sponsor
- MEDA Pharma GmbH & Co. KG
Venous Leg Ulcer
Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg Ulcers
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of venous leg ulcers.
- Trial name
- NCT01552447
- Testing
- EpiFix, Compression Therapy
- Where
- 5 sites in United States
- Volunteers
- 98 people
- Sponsor
- MiMedx Group, Inc.