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

NCT ID: NCT06134843

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-04-15

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.

Conditions

Skin Graft Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DERMASEAL

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.

Group Type: EXPERIMENTAL

DERMASEAL

Intervention Type: COMBINATION_PRODUCT

plasma film containing metallic silver microparticles and fibrin

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DERMASEAL

plasma film containing metallic silver microparticles and fibrin

Intervention Type: COMBINATION_PRODUCT

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).

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vitruvian Medical Devices, Inc.

INDUSTRY

Sponsor Role: collaborator

Hobart W. Harris

INDUSTRY

Sponsor Role: lead

Responsible Party

Hobart W. Harris

President

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David M Young, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF School of Medicine

Central Contacts

David M Young, MD

Role: CONTACT

dyoungucsfplastics@gmail.com

(415) 347-5332

Yukino Nakamura, BA

Role: CONTACT

yukino.nakamura@ucsf.edu

(415) 347-5332

Other Identifiers

VMD2022-002

Identifier Type: -

Identifier Source: org_study_id