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

NCT ID: NCT01993030

Last Updated: 2015-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-09-30

Brief Summary

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.

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.

Conditions

Donor Site Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

HQ® Matrix Medical Wound Dressing

Intervention Type: DEVICE

Sidaiyi® wound dressing

After harvesting the graft, the donor site wounds were treated with the dressing material. Dressing changes if needed.

Group Type: ACTIVE_COMPARATOR

Sidaiyi® wound dressing

Intervention Type: DEVICE

Interventions

HQ® Matrix Medical Wound Dressing

Intervention Type: DEVICE

Sidaiyi® wound dressing

Intervention Type: DEVICE

Other Intervention Names

HQ® Matrix; Sidaiyi®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Xingyue Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital of Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

XY-201301

Identifier Type: -

Identifier Source: org_study_id