Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

Impaired Wound Healing Clinical Trial

— MomelanMohs  

Official title:

Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01442844
• Other study ID #: 2010p002614
• Status: Terminated
• Phase: N/A
• First received: September 27, 2011
• Last updated: June 18, 2014
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impaired Wound Healing

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Mgh Curtis	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Momelan Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Wound Re-epithelialization		4 weeks	No