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Completed

NCT Number: NCT02668042

The Activity of Tissue Engineering Skin Substitutes

The main purpose of this experiment was to evaluate the activity of tissue engineering skin substitutes safety and efficacy studies for the treatment of difficult to heal wounds

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Key information

Conditions

Difficult to Heal Wounds

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

This study for 6 months for a single center, open, randomized, controlled clinical trials before and after itself, test contains preliminary screening, treatment and follow-up after discharge of the patient.After treatment in patients with early debridement, in the case of no infection of living tissue engineering skin substitute transplantation, observe the wound healing after transplantation, chronic wound evaluation activity of tissue engineering skin substitutes in the efficacy and safety of wound healing after transplantation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet difficult had 1 month or more to heal the wound patients
  • Who signed the informed consent of men or women older than 17 (pregnancy)
  • Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years old must be signed by the guardian informed consent
  • The process of mental stability, can finish the test

Exclusion criteria

  • Known allergic to bovine collagen or gao min physique
  • the wound is greater than the10cm×10cm
  • People with mental illness, drug abusers and or other items
  • Pregnant women,Prepare a pregnancy or breast feeding women
  • 3 months participated in other similar experiment
  • Serious infectious disease not controller
  • With surgery, such as severe trauma stress situation
  • Can not meet the requirement of the long-term follow-up of patients

Treatment and study plan

liveness tissue skin

Biological

liveness tissue skin safety and effectiveness for the treatment of difficult to heal wounds

Primary outcomes

  1. Frequency of Adverse Events

    Time frame: 6 months

    Frequency and severity of Adverse Events

Secondary outcomes

  1. Relative Wound Area Regression of 40% or More at 6 Week

    Time frame: 6 week

Other outcomes

  1. Reduced pain

    Time frame: 6 months after treatment

    Reduced pain, measured by VAS scale and use of analgesics

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Living Tissue Engineering Skin Substitutes Safety and Efficacy Studies for the Treatment of Difficult to Heal Wounds

Acronym: MSCs

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2016
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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