NRT(Nara Recell Trauma) Study

JRCT ID: jRCTs052230203

Registered date:13/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Traumatic skin defects
• Date of first enrollment: 13/03/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Off-label use of skin graft kits

Outcome(s)

• Primary Outcome: Healing of the study skin area

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Maegawa Naoki
• Source(s) of Monetary Support: COSMOTEC Co., Ltd.,Nara Medical University