Trial Outcomes & Findings for Evaluation of HQ® Matrix Medical Wound Dressing for Healing of Donor Site Wounds (NCT NCT01993030)

NCT ID: NCT01993030

Last Updated: 2015-06-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 71 participants
• Primary outcome timeframe: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
• Results posted on: 2015-06-19

Participant Flow

Participant milestones

Measure	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	Sidaiyi® Wound Dressing Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing
Overall Study STARTED	36	35
Overall Study COMPLETED	36	31
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Measure	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	Sidaiyi® Wound Dressing Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing
Overall Study Adverse Event	0	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	HQ® Matrix Medical Wound Dressing n=36 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing	Sidaiyi® Wound Dressing n=35 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing	Total n=71 Participants Total of all reporting groups
Age, Continuous	37.39 years STANDARD_DEVIATION 14.29 • n=5 Participants	37.80 years STANDARD_DEVIATION 14.73 • n=7 Participants	37.59 years STANDARD_DEVIATION 14.41 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	19 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	HQ® Matrix Medical Wound Dressing n=36 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing	Sidaiyi® Wound Dressing n=31 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing
Time to Wound Healing	9.86 Days Standard Deviation 1.79	11.35 Days Standard Deviation 3.03

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	HQ® Matrix Medical Wound Dressing n=36 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing	Sidaiyi® Wound Dressing n=35 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing
Number of Participants With Growth of Granulation Tissue Participants with healthy granulation tissue	36 participants	34 participants
Number of Participants With Growth of Granulation Tissue Participants with unhealthy granulation tissue	0 participants	1 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	HQ® Matrix Medical Wound Dressing n=36 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing	Sidaiyi® Wound Dressing n=35 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing
Number of Participants With Inflammatory Reaction Participants with Inflammatory Reaction	1 participants	3 participants
Number of Participants With Inflammatory Reaction Participants without Inflammatory Reaction	35 participants	32 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	HQ® Matrix Medical Wound Dressing n=36 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing	Sidaiyi® Wound Dressing n=35 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing
Pain Perceived by Patient	0.75 units on a scale Standard Deviation 0.91	1.14 units on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: 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 (++);

Outcome measures

Measure	HQ® Matrix Medical Wound Dressing n=36 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing	Sidaiyi® Wound Dressing n=35 Participants Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing
Number of Participants With Exudation Little exudation (+)	0 participants	3 participants
Number of Participants With Exudation No exudation (-)	36 participants	32 participants
Number of Participants With Exudation Much exudation (++)	0 participants	0 participants

Adverse Events

HQ® Matrix Medical Wound Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sidaiyi® Wound Dressing

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HQ® Matrix Medical Wound Dressing n=36 participants at risk Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed HQ® Matrix Medical Wound Dressing	Sidaiyi® Wound Dressing n=35 participants at risk Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed Sidaiyi® wound dressing
Skin and subcutaneous tissue disorders Empyema	0.00% 0/36	8.6% 3/35
Skin and subcutaneous tissue disorders Excessive fluid leakage with odors	0.00% 0/36	2.9% 1/35

Additional Information

Dr. Li Qian

The Second Xiangya Hospital of Central South University

Phone: +86-13958104032

Email: 649418291@qq.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60