Evaluation of HQ® Matrix Medical Wound Dressing for Healing of Donor Site Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhejiang Xingyue Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01993030
First received: November 14, 2013
Last updated: June 2, 2015
Last verified: June 2015
  Purpose

The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Medical Wound Dressing for repair of donor site wounds. Half of participants will receive HQ® Matrix Medical Wound Dressing, while the other half will receive Sidaiyi® wound dressing.


Condition Intervention
Donor Site Wound
Device: HQ® Matrix Medical Wound Dressing
Device: Sidaiyi® 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
Official Title: Randomized, Active-controlled, Single-blind, Parallel Two-group Trial of HQ® Matrix Medical Wound Dressing and Sidaiyi® Wound Dressing for the Treatment of Donor Site Wounds

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

Primary Outcome Measures:
  • Time to Wound Healing [ Time Frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation ] [ Designated as safety issue: No ]
    Healing time was recorded when complete re-epithelialization had occurred. If the wound healed in advance, visit until the wound was completely healed. If the wounds were unable to heal for more than 21±3 days, unanticipated follow-ups were added until the wound was completely healed.


Secondary Outcome Measures:
  • Number of Participants With Growth of Granulation Tissue [ Time Frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation ] [ Designated as safety issue: Yes ]
    Physician assessment of tissue with healthy granulation tissue defined as is granular and uneven in texture, does not bleed easily and is pink in color. Unhealthy granulation tissue is typically dark which can be indicative of poor perfusion, ischemia and/or infection.

  • Number of Participants With Inflammatory Reaction [ Time Frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation ] [ Designated as safety issue: Yes ]
    Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling.

  • Pain Perceived by Patient [ Time Frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation ] [ Designated as safety issue: No ]
    The amount of pain that a patient perceived was assessed using a Visual Analogue Scale (VAS 0-10), which ranges across a continuum from 0 (no pain) to 10 (worst pain).

  • Number of Participants With Exudation [ Time Frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation ] [ Designated as safety issue: Yes ]

    Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation:

    1. Less than two gauze was soaked by exudation within 24h---No exudation (-);
    2. Two to four gauze was soaked by exudation within 24h---Little exudation (+);
    3. More than four gauze was soaked by exudation within 24h---Much exudation (++);


Enrollment: 71
Study Start Date: August 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HQ® Matrix Medical Wound Dressing
After harvesting the graft, the donor site wounds were treated with the dressing material. Dressing changes if needed. An operative removal of the HQ® Matrix Medical Wound Dressing is not required as it becomes spontaneously detached from the regenerated skin areas.
Device: HQ® Matrix Medical Wound Dressing
Other Name: HQ® Matrix
Active Comparator: Sidaiyi® wound dressing
After harvesting the graft, the donor site wounds were treated with the dressing material. Dressing changes if needed.
Device: Sidaiyi® wound dressing
Other Name: Sidaiyi®

Detailed Description:

HQ® Matrix Medical Wound Dressing is a transparent, non-porous, pliable, gas-permeable, and waterproof film dressing which is comprised of silk fibroin protein of the Bombyx mori (B. mori) silkworm. It is intended to provide a moist, gas-permeable and sterile environment to facilitate the normal wound healing process. It is used in the management of non-infected skin defects and various dermal wounds.

Sidaiyi® wound dressing (Suzhou Soho Biomaterial Science and Technology Co., Ltd, Suzhou, China) is a CFDA approved (Su2012-2640182), silk fibroin-based, two-layered spongy dressing. Upon the silk fibroin spongy dressing layer is a membrane made of medical silicone. It is used in the management of partial- and full-thickness wounds, donor site wounds and burns. Currently, it is the sole silk fibroin biomaterial for wound healing that has received regulatory approval worldwide.

  Eligibility

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

Inclusion Criteria:

  1. Patients, aged from 18 - 60, male or female, with wet wounds or burns, ulcerative skin and soft tissue wound surfaces;
  2. The wound surface area ranged from 20cm^2 to 600cm^2;
  3. The patients had a clear mind and there was no misunderstanding;
  4. The patients voluntarily signed the subjects' informed consent form and received timely follow-ups.

Exclusion Criteria:

  1. Patients with active bleeding in wound surfaces;
  2. Vasogenic diseases: patients with no blood supply or phlebothrombosis in local wound tissues;
  3. Those allergic to silk materials;
  4. Those with serious infection;
  5. Those with coagulation disorders;
  6. Those with tumors or diabetes;
  7. Patients who, according to other doctors' opinion, are unsuitable to use this material for wound treatment.
  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

Locations
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Zhejiang Xingyue Biotechnology Co., Ltd.
Investigators
Principal Investigator: Li Qian, PhD Central South University
  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
Results First Received: May 7, 2015
Last Updated: June 2, 2015
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on August 31, 2015