Study of GBT009 for Treatment of Incisional Wounds Following Breast

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Scar Formation

See also
	Status	Clinical Trial	Phase
	Withdrawn	`NCT01750424` - 3-D Imaging Assessment of Scar Formation and Would Healing in Fat Grafted vs Non-Fat Grafted Facial Reconstruction Wound Sites	Phase 1/Phase 2
	Completed	`NCT01454310` - An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns	Phase 4

See also

Status

Clinical Trial

Phase

Withdrawn

NCT01750424 - 3-D Imaging Assessment of Scar Formation and Would Healing in Fat Grafted vs Non-Fat Grafted Facial Reconstruction Wound Sites

Phase 1/Phase 2

Completed

NCT01454310 - An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns

Phase 4

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01053897
Study type	Interventional
Source	Garnet BioTherapeutics, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	January 2010
Completion date	October 2011

Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms