Recruitment

Recruitment Status
Completed
Estimated Enrollment
204

Inclusion Criteria

Patients, aged from 18 - 60, male or female, with wet wounds or burns, ulcerative skin and soft tissue wound surfaces;
The wound surface area ranged from 20cm^2 to 600cm^2;
The patients had a clear mind and there was no misunderstanding;
...
Patients, aged from 18 - 60, male or female, with wet wounds or burns, ulcerative skin and soft tissue wound surfaces;
The wound surface area ranged from 20cm^2 to 600cm^2;
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.

Exclusion Criteria

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

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

Patients, aged from 18 - 60, male or female, with wet wounds or burns, ulcerative skin and soft tissue wound surfaces;
The wound surface area ranged from 20cm^2 to 600cm^2;
The patients had a clear mind and there was no misunderstanding;
...
Patients, aged from 18 - 60, male or female, with wet wounds or burns, ulcerative skin and soft tissue wound surfaces;
The wound surface area ranged from 20cm^2 to 600cm^2;
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.

Exclusion Criteria

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

Locations

Changsha, Hunan, 410013
Changsha, Hunan, 410011
Changsha, Hunan, 410013
Changsha, Hunan, 410011

Tracking Information

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