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Completed

NCT Number: NCT02668055

Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds

Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security.

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Key information

Conditions

Wounds Wounds and Injuries

Age range

17 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

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 5.3 months participated in other similar experiment

6.Serious infectious disease not controller 7.With surgery, such as severe trauma stress situation 8.Can not meet the requirement of the long-term follow-up of patients

Treatment and study plan

TB4

Biological

Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells stick in the wound surface

Primary outcomes

  1. Frequency of Adverse Events

    Time frame: 6 months

    Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing

Secondary outcomes

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

    Time frame: 6week

    Subsistence the wound tissue(4 mm ×4 mm) biopsy samples, to determine the wound repair

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitutes Treatment of Difficult to Heal Wounds Single-center Randomized Parallel Controlled Clinical Studies

Acronym: TB4

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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