N/A
N=71
Evaluation of HQ® Matrix Medical Wound Dressing for Healing of Donor Site Wounds
Donor Site Wound
Bottom Line
View on ClinicalTrials.gov: NCT01993030 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Time to Wound Healing — 9.86; 11.35 Days — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HQ® Matrix Medical Wound Dressing (Device); Sidaiyi® wound dressing (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zhejiang Xingyue Biotechnology Co., Ltd.
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Wound Healing |
9.86; 11.35 | 0.02 sig |
| SECONDARY Number of Participants With Growth of Granulation Tissue |
36; 34; 0; 1 | 0.49 |
| SECONDARY Number of Participants With Inflammatory Reaction |
1; 3; 35; 32 | 0.36 |
| SECONDARY Pain Perceived by Patient |
0.75; 1.14 | 0.11 |
| SECONDARY Number of Participants With Exudation |
36; 32; 0; 3; 0; 0 | 0.11 |
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.
Eligibility Criteria
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;
- The patients voluntarily signed the subjects' informed consent form and received timely follow-ups.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01993030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.