Status:
NOT_YET_RECRUITING
Study to Assess the Safety and Efficacy of DERMASEAL for the Treatment of Split-Thickness Skin Graft Donor Site Wounds
Lead Sponsor:
Hobart W. Harris
Collaborating Sponsors:
Vitruvian Medical Devices, Inc.
Conditions:
Skin Graft Complications
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
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 gr...
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 w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06134843
Start Date
September 1 2024
End Date
April 15 2025
Last Update
June 11 2024
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