Clinical trials: Skin Transplantation
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.
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
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
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
Skin Neoplasms, Kidney Transplantation
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.
- Trial name
- NCT00129961
- Testing
- sirolimus, cyclosporine or tacrolimus
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 86 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Burn, Trauma
Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness skin graft donor sites in patients aged 18-85 years.
- Conditions
- Burn, Trauma, Varicose Ulcer
- Trial name
- NCT00426972
- Testing
- estradiol (Zesteem)
- Where
- 30 sites in Germany, Latvia and 2 more
- Volunteers
- 148 people
- Sponsor
- Renovo
Acute Wound, Traumatic Wound
Confirm the Safety and Performance of Avance Solo NPWT System
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm safety and performance of Avance® Solo NPWT System in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well…
- Conditions
- Acute Wound, Traumatic Wound, Skin Graft, Skin Flap
- Trial name
- ASOLO-SW (NCT04754048)
- Testing
- Avance Solo NPWT System
- Where
- 10 sites in Belgium, France and 2 more
- Volunteers
- 105 people
- Sponsor
- Molnlycke Health Care AB
Rheumatoid Arthritis, Complication of Transplant
Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104
First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
- Trial name
- NCT02800811
- Testing
- FR104
- Where
- Belgium
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- OSE Immunotherapeutics
Bioavailability of ASP015K, Pharmacokinetics of ASP015K
A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K
The purpose of this study is to determine the relative bioavailability and pharmacokinetic profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the safety and tolerability after a single dose of…
- Conditions
- Bioavailability of ASP015K, Pharmacokinetics of ASP015K, Healthy Subjects
- Trial name
- NCT01486017
- Testing
- ASP015K
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Burn Scar, Burn Wound
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery.
- Trial name
- NCT06807021
- Testing
- IP1 control cream (Vehicle base), IP2 - 0.5% w/w FS2
- Where
- 2 sites in Canada
- Volunteers
- 70 people
- Sponsor
- Birch BioMed Inc
Thermal Burn
Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds
The primary objective of the protocol is to evaluate preliminary safety and feasibility of ADRCs via intravenous delivery in the treatment of deep partial and full thickness thermal wounds.
- Trial name
- NCT03435172
- Testing
- Device-ADRCs intravenously infusion
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cytori Therapeutics
Burn Wound
A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG
Burn patients meeting inclusion criteria will receive the esterified hyaluronic acid matrix as the matrix for their wound, in conjunction with the standard of care for managing these types of wounds.
- Trial name
- NCT03723590
- Testing
- Esterified Hyaluronic Acid Matrix
- Volunteers
- 5 people
- Sponsor
- Medline Industries