NCT04532593

Brief Summary

Skin graft is a commonly used method in wound repair. The long-term outcome of skin graft is unsatisfied because of the complications of contraction, pigmentation and stiffness. In our preclinical researches, we found that adipose stem cell can improve the texture of grafted skin and reduce contraction. In this trial, we will evaluate the efficiency and safety of autologous adipose stem cells in improving skin graft outcomes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 21, 2020

Last Update Submit

August 25, 2020

Conditions

Skin Graft

Outcome Measures

Primary Outcomes (1)

  • Skin elasticity

    Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.

    6 months

Secondary Outcomes (11)

  • Skin elasticity

    3 months

  • Skin elasticity

    12 months

  • Skin color

    3 months

  • Skin color

    6 months

  • Skin color

    12 months

  • +6 more secondary outcomes

Study Arms (2)

Stem cell group

EXPERIMENTAL
Procedure: autologous adipose stem cell injection

Control

PLACEBO COMPARATOR
Procedure: saline injection

Interventions

autologous adipose stem cell injectionPROCEDURE

Abdominal or buttock fat will be aspirated under local anesthesia or general anesthesia by conventional methods (0.5 ml fat was aspirated per 1 cm2 of skin graft area). The matrix component rich in adipose stem cells will be obtained by chopping, washing and centrifugation. The intervention treatment will be performed after the skin graft sutured. The stem cell components will be injected underneath the skin graft (0.05 ml/cm2).

Stem cell group
saline injectionPROCEDURE

saline will be injected underneath skin graft (0.05 ml/cm2).

Control

Eligibility Criteria

Age6 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 6-70 years old;
  • Gender: male and female;
  • Scar, surface tumor or soft tissue defect evaluated to be suitable for skin grafting;
  • With two skin grafting areas and the edges more than 4cm apart;
  • Sign informed consent, participate in the study and be able to cooperate with the follow-up.

You may not qualify if:

  • Those who are not suitable for skin grafting;
  • There who are with local lesions in the operation area, such as infection, blood supply disturbance, delayed healing history, decreased soft tissue vitality, history of radiotherapy or going to receive radiotherapy, active ulcer, etc;
  • With severe medical diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, autoimmune diseases, etc.) were complicated;
  • Those who are receiving anticoagulant therapy and cannot suspend treatment;
  • Those who are with abnormal blood routine test, abnormal coagulation function, abnormal cardiac function, abnormal liver function or renal function evaluated by researchers according to the laboratory examination and other clinical signs and symptoms,
  • Those who can't tolerate the operation risk according to the surgeon's evaluation;
  • Pregnant and lactating women;
  • Those who have mental illness, have no insight, can not express and cooperate with each other;
  • Participant in other clinical trials within 30 days before the screen visit of this trial;
  • Those who have not signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Qing-Feng Li

CONTACT

+862123271699shuangbaizhou@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Professor

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 31, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2022

Study Completion

September 30, 2024

Last Updated

August 31, 2020

Record last verified: 2020-08