Recruitment

Recruitment Status
Completed
Estimated Enrollment
204

Inclusion Criteria

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

Exclusion Criteria

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

Summary

Conditions
Donor Site Wound
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

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 wou...

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.

Inclusion Criteria

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

Exclusion Criteria

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

Tracking Information

NCT #
NCT01993030
Collaborators
Not Provided
Investigators
  • Principal Investigator: Li Qian, PhD Central South University
  • Li Qian, PhD Central South University
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