Traumatic skin defects
Conditions
Interventions
Off-label use of skin graft kits
Sponsors
Maegawa Naoki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with skin defects due to trauma (excluding burns caused by flame, excessive heat, or skin exposure to steam or hot water) and skin defects due to flap surgery. 2) Patients with skin defects of 160 cm2 or more, excluding hands and face. 3) Patients at least 16 years of age as of the date consent is obtained. 4) Patients with dermal tissue formation in the study skin area. 5) Patients whose written consent has been obtained from the patient. If the patient is under 18 years of age, written consent must also be obtained from a surrogate.
Exclusion criteria
Exclusion criteria: 1) Patients with hypersensitivity to sodium lactate (washing solution). 2)Patients with hypersensitivity to anesthetics, adrenaline, povidone iodine, chlorhexidine. 3)Patients with allergy to ingredients derived from pigs. 4) Patients who are judged to be unsuitable as subjects by the principal investigator (or subinvestigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of the study skin area | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Scar assessment(VSS: Vancouver Scar Scale) 2) Subject satisfaction after treatment 3) Delayed healing (study skin area) 4) Presence of wound infection 5) Scar requiring surgical intervention 6) Assessment of pain at the study skin area | — |
Contacts
Public ContactNaoki Maegawa
Nara Medical University Hospital
Outcome results
None listed