Clinical trial NCT01993030: Evaluation of HQ® Matrix Medical Wound Dressing for Healing of Donor Site Wounds
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Donor Site Wound
Lead sponsor: Zhejiang Xingyue Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to Wound Healing
timeFrame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Secondary outcomes:
measure: Number of Participants With Growth of Granulation Tissue
timeFrame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
measure: Number of Participants With Inflammatory Reaction
timeFrame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
measure: Pain Perceived by Patient
timeFrame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
measure: Number of Participants With Exudation
timeFrame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Li Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References: