NCT01993030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 19, 2015

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

November 14, 2013

Results QC Date

May 7, 2015

Last Update Submit

June 2, 2015

Conditions

Donor Site Wound

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation

  • Number of Participants With Inflammatory Reaction

    Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation

  • Pain Perceived by Patient

    Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation

  • Number of Participants With Exudation

    Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation

Study Arms (2)

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.

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.

Device: Sidaiyi® wound dressing

Interventions

HQ® Matrix Medical Wound DressingDEVICE
Also known as: HQ® Matrix
HQ® Matrix Medical Wound Dressing
Sidaiyi® wound dressingDEVICE
Also known as: Sidaiyi®
Sidaiyi® wound dressing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Results Point of Contact

Title
Dr. Li Qian
Organization
The Second Xiangya Hospital of Central South University
649418291@qq.com
+86-13958104032

Study Officials

  • Li Qian, PhD

    Second Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 25, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

June 19, 2015

Results First Posted

June 19, 2015

Record last verified: 2015-06

Locations

CN(2)