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

Zhejiang Xingyue Biotechnology

Status: Completed

Conditions: Donor Site Wound

Treatments: Device: HQ® Matrix Medical Wound Dressing; Device: Sidaiyi® wound dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01993030

XY-201301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

HQ® Matrix Medical Wound Dressing

Experimental group

Description:

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.

Treatment:

Device: HQ® Matrix Medical Wound Dressing

Sidaiyi® wound dressing

Active Comparator group

Description:

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

Treatment:

Device: Sidaiyi® wound dressing