Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of HQ™ Matrix Medical Wound Dressing for Healing of Second Degree Burns and Donor Site Wounds

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Zhejiang Xingyue Biotechnology Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Zhejiang Xingyue Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01993030
First received: November 14, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

The purpose of the study is to evaluate the safety and effectiveness of HQ™ Matrix Medical Wound Dressing for the use as a dressing for healing of second degree burns and donor site wounds.


Condition Intervention
Second Degree Burns
Donor Site Wounds
Device: HQ™ Matrix Medical Wound Dressing
Device: Soho® Silk Wound Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Zhejiang Xingyue Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • Wound closure over time [ Time Frame: 21 days post-operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Granulation tissue [ Time Frame: 21days post-operation ] [ Designated as safety issue: Yes ]
  • Wound infection [ Time Frame: 21days post-operation ] [ Designated as safety issue: Yes ]
  • Pain perceived by patient [ Time Frame: 21days post-operation ] [ Designated as safety issue: Yes ]
    VAS scoring

  • Exudation [ Time Frame: 21days post-operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 204
Study Start Date: August 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HQ™ Matrix Medical Wound Dressing Device: HQ™ Matrix Medical Wound Dressing
Dressing indicated for second degree burns and donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Other Name: HQ™ Matrix
Active Comparator: Soho® Silk Wound Dressing Device: Soho® Silk Wound Dressing
Dressing indicated for second degree burns and donor site wounds. Dressing changes every 2-3 days, more frequently if needed
Other Name: Soho®

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-60 years of age; of either gender and in good general health
  • Wounds resulting from second degree burns or donor site wounds
  • Wound size between 20-600 cm²
  • Participant agrees to participate in follow-up evaluation
  • Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

  • Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
  • Participant is to receive another topical antimicrobial agent other than the study dressing
  • Participant with sensitivity or adverse reactions to silver or zinc
  • Pregnancy or nursing an infant or child
  • Immunosuppression
  • Active or systemic infection
  • Peripheral vascular occlusive disease
  • Decision impairment
  • Connective tissue disease
  • Participant undergoing active cancer chemotherapy
  • Chronic steroid use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993030

Contacts
Contact: Jianda Zhou, PhD +86-13508493668 zhoujianda@hotmail.com

Locations
China, Hunan
The Second Xiangya Hospital Recruiting
Changsha, Hunan, China, 410011
Contact: Li Qian    +86-0731-84896038      
Principal Investigator: Li Qian         
The Third Xiangya Hospital Recruiting
Changsha, Hunan, China, 410013
Contact: Jianda Zhou, PhD    +86-13508493668      
Principal Investigator: Jianda Zhou, PhD         
Sponsors and Collaborators
Zhejiang Xingyue Biotechnology Co., Ltd.
Investigators
Principal Investigator: Jianda Zhou, PhD The Third Xiangya Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Xingyue Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01993030     History of Changes
Other Study ID Numbers: XY-201301
Study First Received: November 14, 2013
Last Updated: November 19, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Xingyue Biotechnology Co., Ltd.:
Wound dressing
Second Degree Burns
Donor Site Wounds

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014