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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01993030

Enrollment

Registered

2013-11-25

Start date

2013-08-31

Completion date

2014-09-30

Last updated

2015-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Donor Site Wound

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.

Interventions

DEVICEHQ® Matrix Medical Wound Dressing

DEVICESidaiyi® wound dressing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to Wound Healing	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	Healing time was recorded when complete re-epithelialization had occurred. If the wound healed in advance, visit until the wound was completely healed. If the wounds were unable to heal for more than 21±3 days, unanticipated follow-ups were added until the wound was completely healed.

Secondary

Measure	Time frame	Description
Number of Participants With Growth of Granulation Tissue	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	Physician assessment of tissue with healthy granulation tissue defined as is granular and uneven in texture, does not bleed easily and is pink in color. Unhealthy granulation tissue is typically dark which can be indicative of poor perfusion, ischemia and/or infection.
Number of Participants With Inflammatory Reaction	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling.
Pain Perceived by Patient	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	The amount of pain that a patient perceived was assessed using a Visual Analogue Scale (VAS 0-10), which ranges across a continuum from 0 (no pain) to 10 (worst pain).
Number of Participants With Exudation	Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation	Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation: 1. Less than two gauze was soaked by exudation within 24h---No exudation (-); 2. Two to four gauze was soaked by exudation within 24h---Little exudation (+); 3. More than four gauze was soaked by exudation within 24h---Much exudation (++);

Countries

China

Participant flow

Participants by arm

Arm	Count
HQ® Matrix Medical Wound Dressing Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing	36
Sidaiyi® Wound Dressing Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing	35
Total	71

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	4

Baseline characteristics

Characteristic	HQ® Matrix Medical Wound Dressing	Sidaiyi® Wound Dressing	Total
Age, Continuous	37.39 years STANDARD_DEVIATION 14.29	37.80 years STANDARD_DEVIATION 14.73	37.59 years STANDARD_DEVIATION 14.41
Sex: Female, Male Female	10 Participants	16 Participants	26 Participants
Sex: Female, Male Male	26 Participants	19 Participants	45 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 36	4 / 35
serious Total, serious adverse events	0 / 36	0 / 35

Outcome results

Primary

Time to Wound Healing

Healing time was recorded when complete re-epithelialization had occurred. If the wound healed in advance, visit until the wound was completely healed. If the wounds were unable to heal for more than 21±3 days, unanticipated follow-ups were added until the wound was completely healed.