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Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04234321
Collaborator
The Second Affiliated Hospital of Kunming Medical University (Other), Jiangyin Hospital Affiliated to Southeast University School of Medicine (Other), Nantong University (Other), The 59th Central Hospital of the Chinese people's Liberation Army (Other), Taizhou Central Hospital (Taizhou University Hospital) (Other), Zhejiang Quhua Hospital (Other), Lishui Country People's Hospital (Other)
300
Enrollment
1
Location
3
Arms
29
Anticipated Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: basic fibroblast growth factor
  • Drug: Kangfuxin Liquid
  • Drug: 0.9% Normal saline
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Prospective Clinical Study of Kangfuxin and Basic Fibroblast Growth Factor in Promoting the Healing of Donor Site
Anticipated Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: basic fibroblast growth factor

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

Drug: basic fibroblast growth factor
Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.
Experimental: Kangfuxin Liquid

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

Drug: Kangfuxin Liquid
Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.
Placebo Comparator: 0.9% Normal saline

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

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

Outcome Measures

Primary Outcome Measures

  1. Wound healing rate [up to 2 or 3 weeks]

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

  2. Actual healing time [up to 2 or 3 weeks]

    Means time of complete wound healing

Secondary Outcome Measures

  1. Degree of scar formation [up to 3 or 12 weeks]

    The degree of scar formation .

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • The Second Affiliated Hospital of Kunming Medical University
  • Jiangyin Hospital Affiliated to Southeast University School of Medicine
  • Nantong University
  • The 59th Central Hospital of the Chinese people's Liberation Army
  • Taizhou Central Hospital (Taizhou University Hospital)
  • Zhejiang Quhua Hospital
  • Lishui Country People's Hospital

Investigators

  • Principal Investigator: huawei shao, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04234321
Other Study ID Numbers:
  • IR201900069
First Posted:
Jan 21, 2020
Last Update Posted:
May 12, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
basic fibroblast growth factor,Kangfuxin,Wound Healing
Additional relevant MeSH terms:
Mitogens

Study Results

No Results Posted as of May 12, 2020