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Safety evaluation and clinical effect of superficial-thinkness scalp skin graft in split-thickness skin donor area: a multicenter, randomized, controlled study

Safety evaluation and clinical effect of superficial-thinkness scalp skin graft in split-thickness skin donor area: a multicenter, randomized, controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100055041
Enrollment
Unknown
Registered
2021-12-31
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wound healing

Interventions

test gruop:Take the superficial-thickness skin graft of the scalp and replant it in the medium-thick skin donor area and bandage it locally.
Negative control group:Instead of replantation of the scalp in the donor area of the medium-thick skin, negative pressure suction was performed after the wound was bandaged in the same way as the posi
Positive control group:Instead of replantation of the scalp in the medium-thick skin donor area, the wound in the medium-thick skin donor area was smeared with bFGF growth factor gel and bandaged in t

Sponsors

The First Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1.5 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged from 18 months to 65 years old; 2. Patients who meet the diagnostic criteria, and the palm method evaluates that the area of medium-thickness skin graft is 1%-3% TBSA; 3. Patients or guardians voluntarily participate in the clinical trial and have the ability to understand the content of informed consent. In the case of informed consent, the researchers use the computer to generate random numbers into the group and sign the informed consent form; 4. Hospitalized patients who meet the criteria of medium-thickness skin graft in a long treatment cycle can be enrolled in the group.

Exclusion criteria

Exclusion criteria: 1. Wounds or pressure sores in patients with diabetes mellitus. 2. The surgeon evaluated the patients with high postoperative infection rate. 3. Patients with primary diseases such as severe immunodeficiency. 4. The deceased who suffered serious physical injuries after admission. 5. Pregnant or lactating women. 6. Patients with abnormal blood coagulation, active stage of infection, poor general condition or complicated with cardio-cerebrovascular or hematopoietic system diseases, equipped with cardiac pacemaker. 7. Patients with exposed tendons, nerves, blood vessels or bones. 8. Persons with severe mental illness or psychosomatic disorders. 9. Those who are considered unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Wound healing rate of medium-thick skin donor area;Evaluation of scar quality in split-thickness skin donor area;Healing time of scalp donor area;Satisfaction with the healing of the donor area of the scalp;

Secondary

MeasureTime frame
Evaluation of scar quality in split-thickness skin graft area;The amount of intraoperative bleeding in the donor area of the scalp;Survival rate of skin graft in medium-thickness skin graft area;

Countries

China

Contacts

Public ContactGuanHao

The First Affiliated Hospital of Air Force Medical University

guanhao@hotmail.com+86 13572202874

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026