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

Study Overview
=================
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.

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

Conditions
-----------------
Skin Graft Complications

Intervention / Treatment
-----------------
* Combination Product: DERMASEAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single center, single-blind, randomized, controlled interventional study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DERMASEAL<br>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<br>* plasma film containing metallic silver microparticles and fibrin<br>|
| No Intervention: Standard of Care<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent wound healing | Percent of donor site wounds healed during the post-treatment weeks 1 through 4 | 4 weeks | 
| Time to complete wound closure | Time to complete donor site wound closure during the post-treatment weeks 1 through 4 | 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. | 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. | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, scarring, wound healing