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

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

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.

Study Overview

• Status: Completed
• Conditions: Donor Site Wound
• Intervention / Treatment: Device: HQ® Matrix Medical Wound Dressing; Device: Sidaiyi® wound dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Sidaiyi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Wound Healing	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.	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Growth of Granulation Tissue	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.	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Number of Participants With Inflammatory Reaction	Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling.	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Pain Perceived by Patient	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).	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Number of Participants With Exudation	Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation: Less than two gauze was soaked by exudation within 24h---No exudation (-);; Two to four gauze was soaked by exudation within 24h---Little exudation (+);; More than four gauze was soaked by exudation within 24h---Much exudation (++);	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation

Collaborators and Investigators

• Sponsor: Zhejiang Xingyue Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Li Qian, PhD, Central South University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 14, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: XY-201301