Impaired Wound Healing
Conditions
Keywords
Mohs, Scalp
Brief summary
This study evaluates a novel micrografting technique to see how it will influence the healing rate and cosmetic result of second intention wounds. The graft harvesting and micrografting process was designed by MoMelan Technologies The Epidermal Expansion System, which is composed of a commercially available Blister Generation Device and the Microblister Generation and Excision Device (MBGED), will generate an array of small microblisters and transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing) for application to the subject's surgical area. The investigators predict that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possible reduce scarring.
Detailed description
Participants with a scalp wound s/p Mohs procedure will be randomized to a micrografting technique intervention or to no intervention/heal with secondary intention alone (control). Intervention consists of harvesting skin micrografts (1.75mm) from pigmented skin using the Microblister generation and excision device and transfer the micrografts to a sterile dressing for application to the participants scalp wound. Percent wound re-epithelialization will be compared between two groups.
Interventions
DEVICEMicrografting
Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
Sponsors
Momelan Technologies
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Between 40-75 years old 2. Status post Mohs procedure on the scalp with a wound that would otherwise be allowed to heal by second intention 3. Superficial would-at deepest of 2.0 mm or to superficial fat, but not deep to muscle 4. Area is less then 6 cm2 (wound diameter less than 2cm)
Exclusion criteria
1. Female patients who are breastfeeding, pregnant, or planning to become pregnant 2. Abnormal bleeding observed during initial Mohs procedure that would suggest a higher risk of post-operative bleeding 3. Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent 4. Participation in another interventional study with potential exposure to an investigational drug within past 30 days or planned study entry within 90 days after study entrance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Wound Re-epithelialization | 4 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Micrografting Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound. | 1 |
| No Intervention No intervention will be performed. Subject will receive dressings that are standard of care. | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Micrografting | No Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Continuous | 74 years | 66.5 years | 69 years |
| Region of Enrollment United States | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
Percentage of Wound Re-epithelialization
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Micrografting | Percentage of Wound Re-epithelialization | 50 percentage of wound re-epithelialization |
| No Intervention | Percentage of Wound Re-epithelialization | 37.5 percentage of wound re-epithelialization |