Skin Graft ComplicationsPhase 1/2NCT06134843
Study to Assess the Safety and Efficacy of DERMASEAL for the Treatment of Split-Thickness Skin Graft Donor Site Wounds
A Phase 1/2 study testing DERMASEAL in people with Skin Graft Complications, run by Hobart W. Harris.
Trial summary
The goal of this study to determine whether the combination biologic/drug DERMASEAL will safely decrease donor wound pain after split-thickness skin graft surgery. Participants will have their skin graft donor sites immediately treated with DERMASEAL versus standard of care wound dressings followed by periodic… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Graft Complications
- What is being tested?
- DERMASEAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 15 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women ≥ 21 years of age.
- The subject is able and willing to adhere to study procedures and informed consent is obtained.
- Patient scheduled to undergo a split-thickness skin graft > 25 cm2 and ≤ 300 cm2 with a wound depth of between 0.010 - 0.015 inch (0.2 - 0.4 mm).
- Target donor site wound involving the torso or upper or lower extremities.
- Patient has a palpable pulse at the wrist or ankle indicating adequate arterial perfusion of the extremity from which the skin graft is harvested.
- Serum creatinine <2.0 mg/dl within the last 6 months.
- Negative urine pregnancy test at screening for women of childbearing potential. i) Women participants are considered of non-childbearing potential if they are pre-menopausal with a documented hysterectomy or bilateral oophorectomy; or post-menopausal defined as the cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; or have a serum FSH level confirming the post-menopausal state.
Who cannot join
- Hypersensitivity to silver or fresh frozen plasma.
- Active infection or history of radiation to the donor site.
- Insensate at the donor site.
- Elevated INR>3.0.
- The subject was previously entered into this study or had participated in any study drug or medical device study within 30 days of screening.
- Currently on a treatment regimen or medications which in the opinion of the investigator are known to interfere with wound healing (for example: cancer chemotherapy or equivalent immunosuppressants, systemic steroids > 10 days of treatment, cytostatic drugs, COX-2 inhibitors, or radiation therapy).
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- Excessive lymphedema that in the opinion of the investigator will interfere with wound healing.
- A cognitive, physical, or psychological condition interfering with subject's ability to comply with the treatment regimen.
- Subject is on dialysis.
- Patients who are pregnant, breast feeding, or unwilling to practice contraceptive methods during participation in the study, if applicable. Effective methods of contraception include:
- oral, injectable, or implanted hormonal contraceptives ii. intrauterine device or system, iii. barrier method with spermicide, or iv. bilateral tubal occlusion.
- Patients with uncontrolled anemia (Hgb<10 g/dL in women; <12 g/dL in men) at Screening.
- Severe malnutrition (serum albumin ≤2.0 with a normal CRP).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-Blind, Randomized, Controlled, Single Center Clinical Study to Assess the Safety and Efficacy of DERMASEAL Advanced Wound Care Dressing for the Treatment of Split-Thickness Skin Graft Donor Site Wounds
The goal of this study to determine whether the combination biologic/drug DERMASEAL will safely decrease donor wound pain after split-thickness skin graft surgery. Participants will have their skin graft donor sites immediately treated with DERMASEAL versus standard of care wound dressings followed by periodic monitoring of their recovery.
Read the detailed description
This is a single center, single-blind, randomized, controlled phase 1/2 study of patients undergoing treatment of a cutaneous wound involving a split-thickness skin graft. A subject's study duration will be for up to a total of 16 weeks from randomization to end of study. This includes 1 week of treatment, followed by 3 weeks of Standard of Care plus a final follow-up visit 12 weeks after complete wound closure or the end of Standard of Care.
- Conditions
- Skin Graft Complications
- Being tested
- DERMASEAL
- Keywords
- pain, scarring, wound healing
- Medical subject headings
- Pain, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DERMASEALCombination product
plasma film containing metallic silver microparticles and fibrin
| Study group | Role | What they receive |
|---|---|---|
| DERMASEAL | Experimental | DERMASEAL will be placed to completely cover the donor site wound. The entire site will then be covered with a transparent film dressing (TegadermTM, 3M) with at least 3 cm margin of normal skin under the film dressing before securing it with kerlix gauze and an ace wrap bandage placed circumferentially around the extremity.
The dressing will be left on the donor site wound until the wound is completely closed or changed at the discretion of the treating team. Receives: Combination Product: DERMASEAL |
| Standard of Care | No intervention | The donor site wound is covered with a transparent film dressing (TegadermTM, 3M) with at least 3 cm margin of normal skin under the film dressing. The dressing is then secured with kerlix gauze and ace wrap bandage placed circumferentially around the extremity. The dressing will be left on the donor site wound until the wound is completely closed or changed at the discretion of the treating team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
The safety of topically applying a plasma film containing metallic silver microparticles plus fibrin in patients with skin graft donor sites for 16 weeks following split-thickness skin grafting.
Measured: 16 weeks
wound pain
The study will evaluate if using DERMASEAL is associated with a clinically meaningful difference in pain score (≥2 points on the Visual Analog Scale; minimal score =0 and maximal score = 10. A higher score means more pain) between the treatment and active control arms at any time during the 16-week study.
Measured: 16 weeks
Secondary outcomes (4)
Percent wound healing
Percent of donor site wounds healed during the post-treatment weeks 1 through 4
Measured: 4 weeks
Time to complete wound closure
Time to complete donor site wound closure during the post-treatment weeks 1 through 4
Measured: 4 weeks
Recurrent donor site wound after complete wound closure
Recurrence of donor site after complete wound closure, requiring treatment, at any time during the 16-week study.
Measured: 16 weeks
Scarring
Scarring as measured by the Vancouver Scar Scale at 16 weeks after surgery. The minimum value = 0 and maximal value = 13; higher scores mean a worse outcome.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Sep 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Graft ComplicationsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single center, single-blind, randomized, controlled interventional study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hobart W. Harris
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vitruvian Medical Devices, Inc.
- Responsible party
- Sponsor-investigator, Hobart W. Harris, Vitruvian Medical Devices, Inc.
- Investigators
- David M Young, MD, Principal investigator, UCSF School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134843
- Sponsor's protocol ID
- VMD2022-002
- Status last verified
- Jun 2024
- First submitted
- 4 Nov 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized, Controlled, Single Center Clinical Study to Assess the Safety and Efficacy of DERMASEAL Advanced Wound Care Dressing for the Treatment of Split-Thickness Skin Graft Donor Site Wounds
- ClinicalTrials.gov ID
- NCT06134843
- Acronym / sponsor ID
- VMD2022-002
- Conditions
- Skin Graft Complications
- Keywords
- pain, scarring, wound healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hobart W. HarrisIndustry (pharma, biotech, devices)
- Collaborators
- Vitruvian Medical Devices, Inc.
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study to determine whether the combination biologic/drug DERMASEAL will safely decrease donor wound pain after split-thickness skin graft surgery. Participants will have their skin graft donor sites immediately treated with DERMASEAL versus standard of care wound dressings followed by periodic monitoring of their recovery.
Detailed description
This is a single center, single-blind, randomized, controlled phase 1/2 study of patients undergoing treatment of a cutaneous wound involving a split-thickness skin graft. A subject's study duration will be for up to a total of 16 weeks from randomization to end of study. This includes 1 week of treatment, followed by 3 weeks of Standard of Care plus a final follow-up visit 12 weeks after complete wound closure or the end of Standard of Care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- single center, single-blind, randomized, controlled interventional study
| Arm | Type | Receives |
|---|---|---|
| DERMASEAL | Experimental | Combination Product: DERMASEALDERMASEAL will be placed to completely cover the donor site wound. The entire site will then be covered with a transparent film dressing (TegadermTM, 3M) with at least 3 cm margin of normal skin under the film dressing before securing it with kerlix gauze and an ace wrap bandage placed circumferentially around the extremity. The dressing will be left on the donor site wound until the wound is completely closed or changed at the discretion of the treating team. |
| Standard of Care | No intervention | –The donor site wound is covered with a transparent film dressing (TegadermTM, 3M) with at least 3 cm margin of normal skin under the film dressing. The dressing is then secured with kerlix gauze and ace wrap bandage placed circumferentially around the extremity. The dressing will be left on the donor site wound until the wound is completely closed or changed at the discretion of the treating team. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women ≥ 21 years of age.
- The subject is able and willing to adhere to study procedures and informed consent is obtained.
- Patient scheduled to undergo a split-thickness skin graft > 25 cm2 and ≤ 300 cm2 with a wound depth of between 0.010 - 0.015 inch (0.2 - 0.4 mm).
- Target donor site wound involving the torso or upper or lower extremities.
- Patient has a palpable pulse at the wrist or ankle indicating adequate arterial perfusion of the extremity from which the skin graft is harvested.
Key exclusion criteria (13 listed)
- Hypersensitivity to silver or fresh frozen plasma.
- Active infection or history of radiation to the donor site.
- Insensate at the donor site.
- Elevated INR>3.0.
- The subject was previously entered into this study or had participated in any study drug or medical device study within 30 days of screening.
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 |
|---|---|---|
| DERMASEALplasma film containing metallic silver microparticles and fibrin | Combination product | DERMASEAL |
Primary outcome
adverse events
Time frame: 16 weeks
The safety of topically applying a plasma film containing metallic silver microparticles plus fibrin in patients with skin graft donor sites for 16 weeks following split-thickness skin grafting.
wound pain
Time frame: 16 weeks
The study will evaluate if using DERMASEAL is associated with a clinically meaningful difference in pain score (≥2 points on the Visual Analog Scale; minimal score =0 and maximal score = 10. A higher score means more pain) between the treatment and active control arms at any time during the 16-week study.
4 secondary outcomes
Percent wound healing
Time frame: 4 weeks
Time to complete wound closure
Time frame: 4 weeks
Recurrent donor site wound after complete wound closure
Time frame: 16 weeks
Scarring
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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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.
David M Young, MD principal investigator
UCSF School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DERMASEAL in people with Skin Graft Complications, run by Hobart W. Harris.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David M Young, MD ((415) 347-5332, dyoungucsfplastics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 11 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.