NCT04234321

Brief Summary

The main objective of this study is to observe whether basic fibroblast growth factor and Kangfuxin Liquid can promote the wound healing in the donor area and further evaluate the healing quality.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 12, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

January 4, 2020

Last Update Submit

May 8, 2020

Conditions

Fibroblast Growth FactorsWound Healing

Keywords

basic fibroblast growth factor,Kangfuxin,Wound Healing

Outcome Measures

Primary Outcomes (2)

  • Wound healing rate

    Means (wound area before treatment - wound area after treatment) / wound area before treatment × 100%.

    up to 2 or 3 weeks

  • Actual healing time

    Means time of complete wound healing

    up to 2 or 3 weeks

Secondary Outcomes (1)

  • Degree of scar formation

    up to 3 or 12 weeks

Study Arms (3)

basic fibroblast growth factor

EXPERIMENTAL

Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.

Drug: basic fibroblast growth factor

Kangfuxin Liquid

EXPERIMENTAL

Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.

Drug: Kangfuxin Liquid

0.9% Normal saline

PLACEBO COMPARATOR

0.9% Normal saline,20ml / 100cm2 / time,three times a day.

Drug: 0.9% Normal saline

Interventions

basic fibroblast growth factorDRUG

Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.

basic fibroblast growth factor
Kangfuxin LiquidDRUG

Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.

Kangfuxin Liquid
0.9% Normal salineDRUG

0.9% Normal saline,20ml / 100cm2 / time,three times a day.

0.9% Normal saline

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male / female patients aged 20-50;
  • Burn area ≤ 30% TBSA;
  • Patients who need auto skin grafting due to burns or skin defects due to trauma;
  • The donor area is 100cm2, and the thickness of skin is 0.25mm (Split thickness skin donor site group)/0.40mm (Medium thickness skin donor site group). The donor site is the body part with similar skin color and sufficient skin area (except scalp);
  • Not involved in clinical trials of other drugs;
  • Subjects who have agreed to participate in the clinical study and signed the informed consent.

You may not qualify if:

  • Subjects who were previously allergic to similar products or related components of test products;
  • Subjects with other systemic or local skin diseases that may affect wound evaluation;
  • Subjects with significant organ dysfunction / failure or other serious diseases, including clinical related cardiovascular disease or myocardial infarction within 12 months before enrollment; malignant tumor; serious neurological or psychiatric history; serious infection; active disseminated intravascular coagulation;
  • Subjects with moderate malnutrition (BMI \< 17kg / m2) and severe anemia (HB \< 60g / L);
  • Subjects proposed to use immunosuppressant, steroid hormone, epidermal growth factor and other drugs that may affect the wound healing of the donor skin within 3 months before admission or during the study period;
  • Participated in clinical trials of any other drugs or medical devices within 3 months;
  • History of major diseases that may affect general physical condition and other patients who are not considered by the researchers to be eligible for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Fibroblast Growth Factor 2Saline Solution

Intervention Hierarchy (Ancestors)

Fibroblast Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • huawei shao, MD

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

huawei shao, MD

CONTACT

139898807612504131@zju.edu.cn

chunmao han, MD

CONTACT

0571 87783759hanchunmao1@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 21, 2020

Study Start

August 1, 2020

Primary Completion

June 30, 2022

Study Completion

December 31, 2022

Last Updated

May 12, 2020

Record last verified: 2020-01

Locations

CN(1)