NCT Number: NCT06287866
Oftentimes, following surgery on the scalp, wounds are left to heal by themselves. This is called "second intention." Open wounds left to heal on the scalp often take 8 weeks or more to completely heal. The investigators are investigating how second intention closure compares to another established reconstruction technique, called "pinch graft." In the pinch graft technique, a dermatological surgeon numbs and then shaves off a thin piece of skin (usually from the groin area) and places it in the wound bed it (also known as "grafting"), to encourage growth of new healthy skin. This study will compare time-to-healing in the second intention method versus the pinch graft method.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Sacramento, California, 95816, United States
Location status: Recruiting
Daniel Eisen, MD
CONTACT
Daniel Eisen, MD
PRINCIPAL_INVESTIGATOR
Ilana Breen, MD
SUB_INVESTIGATOR
John Robb, BS
CONTACT
Keemberly Kim, MD
SUB_INVESTIGATOR
Pinch graft methodology was first developed in 1976 as a treatment to accelerate healing of lower leg ulcerations, particularly venous or gravitational ulcerations (1, 2). It was later adapted as a tool to hasten healing in surgical wounds, such as surgical closure of diabetic foot wounds (3). It has also been used in the healing of patients with wounds related to dystrophic epidermolysis bullosa (4). More recently, pinch grafts have been investigated as a reconstruction option for Mohs micrographic surgery defects (5). In this study, patients with below the knee Mohs surgical defects were randomized to receive either PG reconstruction or SIH reconstruction. Patients with PG reconstruction healed 20 days sooner (i.e., faster time to reepithelialization) than those who underwent SIH. Complication rates, including infection and reported pain, were also lower in the PG cohort compared to the SIH cohort. SIH is often recommended as a reconstruction technique for surgical wounds without adjacent skin laxity to support primary closure, such as the anterior lower extremity and scalp. There is no study to date examining the use of pinch grafts in scalp wounds. In our study, the investigators explore whether PG is a viable and useful reconstruction method for wounds on the scalp that otherwise would be left to close via SIH. Specifically, in our study, the investigators examine the comparative time to healing and complication rates between PG and SIH in Mohs surgical defects of the scalp.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the pinch graft technique, the investigators will numb and then shave off a thin piece of skin and place it in the wound bed.
Time frame: 1-8 weeks
Participants will submit weekly photos to blinded reviewers to assess for re-epithelization.
Time frame: 3 months
The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.
Time frame: 3 months
This is the patient portion of the POSAS assessment, which will be independently recorded. The patient scale of the POSAS consists of six items (pain, itch, thickness, color, stiffness, and irregularity). All items are scored on a scale ranging from 1 ("as normal skin") to 10 ("yes, very different"). The sum of the six items results in a total score of the POSAS patient scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.
Contact information is provided by the study sponsor or research team.
John Robb, BS, BA
CONTACT
Keemberly Kim, MD
CONTACT
University of California, Davis
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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