Treatment of donor sites using a non cultured autologous cell suspension: A randomized controlled trial

UMIN ID: UMIN000015000

Registered date:10/09/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: people who had donor site after skin grafted
• Date of first enrollment: 2014/09/10
• Target sample size: 106
• Countries of recruitment: Asia(except Japan)
• Study type: Interventional

Intervention(s)

ReCell group
control group

Outcome(s)

• Primary Outcome: healing time

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria consisted in the presence of pre-existing local and systemic bacterial infections, pre-existing medical conditions that would interfere with wound healing (diabetes, malignancy, autoimmune disease), renal failure (glomerular filtration rate inferior to 60 ml/min), medications that could interfere with wound healing (corticosteroids), hypersensitivity to Trypsin or Hartmann's solution, a high anesthesiology risk that necessarily postponed surgery.

Related Information

• Primary Sponsor: Zhu Jia-Yuan
• Source(s) of Monetary Support: National Natural Science Foundation of China (No. 81272096), Sun Yat-sen University Clinical Research 5010 Program (No. 2013001)