Clinical trial NCT06134843: Study to Assess the Safety and Efficacy of DERMASEAL for the Treatment of Split-Thickness Skin Graft Donor Site Wounds
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Skin Graft Complications
Keywords: pain
scarring
wound healing
Lead sponsor: Vitruvian Medical Devices, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vitruvian Medical Devices, Inc.
First posted: 2023-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single center, single-blind, randomized, controlled interventional study
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Men or women ≥ 21 years of age.
2. The subject is able and willing to adhere to study procedures and informed consent is obtained.
3. 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).
4. Target donor site wound involving the torso or upper or lower extremities.
5. Patient has a palpable pulse at the wrist or ankle indicating adequate arterial perfusion of the extremity from which the skin graft is harvested.
6. Serum creatinine \<2.0 mg/dl within the last 6 months.
7. 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.

Exclusion Criteria:

1. Hypersensitivity to silver or fresh frozen plasma.
2. Active infection or history of radiation to the donor site.
3. Insensate at the donor site.
4. Elevated INR\>3.0.
5. The subject was previously entered into this study or had participated in any study drug or medical device study within 30 days of screening.
6. 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).
7. Excessive lymphedema that in the opinion of the investigator will interfere with wound healing.
8. A cognitive, physical, or psychological condition interfering with subject's ability to comply with the treatment regimen.
9. Subject is on dialysis.
10. Patients who are pregnant, breast feeding, or unwilling to practice contraceptive methods during participation in the study, if applicable. Effective methods of contraception include:

    i. oral, injectable, or implanted hormonal contraceptives ii. intrauterine device or system, iii. barrier method with spermicide, or iv. bilateral tubal occlusion.
11. Patients with uncontrolled anemia (Hgb\<10 g/dL in women; \<12 g/dL in men) at Screening.
12. Severe malnutrition (serum albumin ≤2.0 with a normal CRP).

Primary outcomes:
measure: adverse events
timeFrame: 16 weeks
measure: wound pain
timeFrame: 16 weeks
Secondary outcomes:
measure: Percent wound healing
timeFrame: 4 weeks
measure: Time to complete wound closure
timeFrame: 4 weeks
measure: Recurrent donor site wound after complete wound closure
timeFrame: 16 weeks
measure: Scarring
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: UCSF School of Medicine
name: David M Young, MD
role: PRINCIPAL_INVESTIGATOR
References: