Effect of combination of basic fibroblast growth factor and heparin on skin graft donor site healing

JRCT ID: jRCT1041230082

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Split-thickness skin graft harvesting wound with dermatome
• Date of first enrollment: 05/08/2020
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Patients are randomly allocated to either the control or intervention group at a 1:1 ratio before surgery. All STSGs are harvested from the lateral thigh at a depth of 12/1000 inches using an air-powered dermatome. After achieving complete hemostasis, donor sites are covered with a chitin film. From the next day, the allocated treatment is administered. The control group (six patients) will receive standard treatment with bFGF and white petrolatum, whereas the intervention group (six patients) will receive treatment with the topical formulation prepared by mixing bFGF solution with heparin ointment. Patients receive the allocated treatment every day until the wound heals.

Outcome(s)

• Primary Outcome: Epithelialized area (or wound area) of skin harvested site at 4 weeks postoperatively

Secondary Outcome

1, Epithelialized area (or wound area) of skin harvested site at 4, 7,11,14,18, 21, 25, and 28 days postoperatively (the number of days required for complete epithelialization)
2, Epithelialized area (or wound area) variation of skin harvested site at 4, 7,11,14,18, 21, 25, and 28 days postoperatively
3, Relationship of patient characteristics and blood test results with the epithelialization

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Underwent split-thickness skin graft (STSG) harvesting from the thigh for reconstructive surgery
Aged 20 >= years who signed an informed consent form
Provide written consent for participation in this study from the individual or a legal representative

Exclude criteria

Showed bleeding tendencies
Deemed inappropriate by the principal investigator

Related Information

• Primary Sponsor: Kohyama Keishi
• Secondary Sponsor: Okada Hideshi