Study to Assess the Safety and Efficacy of DERMASEAL for the Treatment of Split-Thickness Skin Graft Donor Site Wounds

NCT06134843 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: VMD2022-002
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Graft Complications

Keywords

pain; scarring; wound healing

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  16 weeks

Secondary Outcomes (4)

• Percent wound healing

  4 weeks

• Time to complete wound closure

  4 weeks

• Recurrent donor site wound after complete wound closure

  16 weeks

• Scarring

  16 weeks

Study Arms (2)

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.

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.

Interventions

DERMASEAL COMBINATION_PRODUCT

plasma film containing metallic silver microparticles and fibrin

DERMASEAL

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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:
• i. 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).

Sponsors & Collaborators

• Hobart W. Harris: lead
• Vitruvian Medical Devices, Inc.: collaborator

MeSH Terms

Conditions

Pain; Cicatrix

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Study Officials

• David M Young, MD

  UCSF School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David M Young, MD

CONTACT

(415) 347-5332; dyoungucsfplastics@gmail.com

Yukino Nakamura, BA

CONTACT

(415) 347-5332; yukino.nakamura@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessors will evaluate pain and scarring using the Visual Analog Scale (VAS) Vancouver Scar Scale (VSS) without knowledge of the participants' treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Model Details: single center, single-blind, randomized, controlled interventional study

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 18, 2023
• Study Start: September 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: April 15, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share