Donor Site WoundNCT01993030
Evaluation of HQ® Matrix Medical Wound Dressing for Healing of Donor Site Wounds
A study testing HQ® Matrix Medical Wound Dressing and Sidaiyi® wound dressing in people with Donor Site Wound, run by Zhejiang Xingyue Biotechnology Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Donor Site Wound
- What is being tested?
- HQ® Matrix Medical Wound Dressing and Sidaiyi® wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with active bleeding in wound surfaces;
- Vasogenic diseases: patients with no blood supply or phlebothrombosis in local wound tissues;
- Those allergic to silk materials;
- Those with serious infection;
- Those with coagulation disorders;
- Those with tumors or diabetes;
- Patients who, according to other doctors' opinion, are unsuitable to use this material for wound treatment.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
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
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.
Read the 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.
- Conditions
- Donor Site Wound
- Being tested
- HQ® Matrix Medical Wound Dressing, Sidaiyi® wound dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HQ® Matrix Medical Wound DressingDevice
Also called HQ® Matrix
Sidaiyi® wound dressingDevice
Also called Sidaiyi®
| Study group | Role | What they receive |
|---|---|---|
| HQ® Matrix Medical Wound Dressing | Experimental | 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. Receives: Device: HQ® Matrix Medical Wound Dressing |
| Sidaiyi® wound dressing | Active comparator | After harvesting the graft, the donor site wounds were treated with the dressing material. Dressing changes if needed. Receives: Device: Sidaiyi® wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Secondary outcomes (4)
Number of Participants With Growth of Granulation Tissue
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.
Measured: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Number of Participants With Inflammatory Reaction
Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling.
Measured: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Pain Perceived by Patient
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).
Measured: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Number of Participants With Exudation
Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation:
- Less than two gauze was soaked by exudation within 24h---No exudation (-);
- Two to four gauze was soaked by exudation within 24h---Little exudation (+);
- More than four gauze was soaked by exudation within 24h---Much exudation (++);
Measured: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Donor Site WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Xingyue Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Qian, PhD, Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993030
- Sponsor's protocol ID
- XY-201301
- Status last verified
- Jun 2015
- First submitted
- 14 Nov 2013
- Last updated
- 19 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01993030
- Acronym / sponsor ID
- XY-201301
- Conditions
- Donor Site Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Zhejiang Xingyue Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 19 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HQ® Matrix Medical Wound Dressing | Experimental | Device: HQ® Matrix Medical Wound DressingAfter 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. |
| Sidaiyi® wound dressing | Active comparator | Device: Sidaiyi® wound dressingAfter harvesting the graft, the donor site wounds were treated with the dressing material. Dressing changes if needed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients with active bleeding in wound surfaces;
- Vasogenic diseases: patients with no blood supply or phlebothrombosis in local wound tissues;
- Those allergic to silk materials;
- Those with serious infection;
- Those with coagulation disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HQ® Matrix Medical Wound DressingAlso: HQ® Matrix | Device | HQ® Matrix Medical Wound Dressing |
| Sidaiyi® wound dressingAlso: Sidaiyi® | Device | Sidaiyi® wound dressing |
Primary outcome
Time to Wound Healing
Time frame: 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.
4 secondary outcomes
Number of Participants With Growth of Granulation Tissue
Time frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Number of Participants With Inflammatory Reaction
Time frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Pain Perceived by Patient
Time frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Number of Participants With Exudation
Time frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Qian, PhD principal investigator
Second Xiangya Hospital of Central South University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HQ® Matrix Medical Wound Dressing and Sidaiyi® wound dressing in people with Donor Site Wound, run by Zhejiang Xingyue Biotechnology Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Wound Healing (time frame: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.