Trial Summary
What is the purpose of this trial?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.
What safety data exists for pinch grafting or similar treatments for scalp wounds?The safety data for treatments like pinch grafting, also known as split-thickness skin grafting, indicates that complications are generally minor in adults but can include excessive blood loss in children due to the large surface area of the scalp. Studies show minimal risk of pathological scarring at the donor site in both children and adults. A 'graft back' method for donor site management has shown good outcomes with minimal complications, suggesting it may reduce healing time and improve cosmetic results. However, more detailed studies are needed to confirm these findings. Overall, the procedure appears to have minimal morbidity, especially in healthy patients.456810
What data supports the idea that Pinch Grafting for Scalp Wounds is an effective treatment?The available research shows that pinch grafting, a type of skin grafting, is effective for treating stubborn skin ulcers. It can be combined with new surgical dressings to speed up healing and improve graft survival. While the research doesn't directly compare pinch grafting to other treatments for scalp wounds, it highlights its effectiveness in similar conditions, suggesting it could be beneficial for scalp wounds as well.3791011
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is Pinch Graft a promising treatment for scalp wounds?Yes, Pinch Graft is a promising treatment for scalp wounds. It uses small pieces of skin to help heal difficult skin ulcers effectively. The scalp is a great place to get these skin pieces because it heals quickly, and hair regrowth hides the area. This method can speed up healing and improve the success of the grafts.123911
Eligibility Criteria
This trial is for individuals with scalp wounds from surgery, specifically Mohs micrographic surgery. The study aims to compare two healing methods: letting the wound heal on its own or using a pinch graft technique where skin from another area is placed in the wound.Treatment Details
The study tests how quickly scalp wounds heal when left alone (second intention) versus when treated with a pinch graft, which involves transplanting a small piece of skin from elsewhere on the body to the wound site.
2Treatment groups
Experimental Treatment
Active Control
Group I: Pinch GraftingExperimental Treatment1 Intervention
Group II: Second Intention Wound HealingActive Control1 Intervention
Pinch Graft is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Pinch Grafting for:
- Wound healing
- Surgical wound defects
- Mohs micrographic surgery defects
🇪🇺 Approved in European Union as Pinch Grafting for:
- Wound healing
- Chronic wounds
- Surgical wound defects
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of California, Davis - Dermatology DepartmentSacramento, CA
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Who is running the clinical trial?
University of California, DavisLead Sponsor
References
Scalp as a donor site. [2019]Our experience in twenty-six patients suggests that the scalp is an excellent source of split thickness skin grafts. Healing is rapid, infection is rare, and the regrowth of hair conceals the donor site.
Slit grafting: the use of serrated island grafts in male and female-pattern alopecia. [2019]Successful aesthetic treatment of earlier thinning of scalp hair in men and women has necessitated the development of alternatives to traditional punch grafting. The hair-bearing "serrated island" remaining between two parallel rows of round donor sites can be removed and dissected to yield a large number of "serrated island grafts" and single-hair grafts. These miniature grafts, along with half grafts from bisected plugs, can be placed, in one or several sessions, into dozens to hundreds of small "slits" between the remaining hairs in patients with early or advanced thinning on the crown, vertex, or anterior scalp--hence the name "slit grafting." The versatility of this technique is demonstrated by its value for patients with dark hair and light skin, in repair work, in patients necessitating extensive vertex coverage, or in combination with alopecia reduction and traditional punch grafting. The finely tufted progressive growth from hundreds of these carefully placed slit grafts can thus counteract further hair loss in a variety of different situations.
The technique and current status of pinch grafting. [2019]Small split-thickness skin grafts, also known as pinch grafts, can provide an effective form of therapy for recalcitrant ulcers of the skin. Several of the new surgical dressings can be combined with the traditional pinch grafting technique to shorten the time for the development of granulation tissue within a clean ulcer base and improve the survival of the grafts themselves. This paper will summarize the surgical technique employed in pinch grafting.
A review of scalp split-thickness skin grafts and potential complications. [2019]A review of 113 patients who underwent 178 scalp split-thickness skin graft procedures is presented. Although our study confirms some of the work of previous authors, we found that the scalp donor site has potential complications which should be considered. These complications are minor in the adult population. In the pediatric population, however, excessive blood loss due to the relatively large surface area of the scalp limits the use of the scalp as a preferred donor site.
Skin harvesting on the scalp in children: utopia or reality. [2004]Since 1990 we have used systematically the scalp as donor site for split skin graft in children. The aim of this retrospective and prospective study is to analyse the results, advantages, disadvantages, complications and problems of this method.
Absence of pathological scarring in the donor site of the scalp in burns: an analysis of 295 cases. [2010]This study aims to describe the incidence of complications on scalp from which a thin split-skin graft was harvested (0.005-0.007 in.) of the donor site in children and adult burn victims.
[Clinical study of repairing donor site of thickness from cicatricial skin with auto-scalp grafting]. [2013]To study the effects of using auto-scalp for repairing donor site of thickness from cicatricial skin with auto-scalp grafting.
Back Grafting the Split-Thickness Skin Graft Donor Site. [2018]Split-thickness skin grafting is a useful method of wound repair in burn and reconstructive operations. However, skin grafts require a donor site injury that creates a secondary wound at risk for delayed wound healing. Though in young healthy patients such donor sites have minimal risk, patients with risk factors for delayed wound healing are more challenging. We present a method for graft donor site management that offers an alternative to healing by secondary intention for patients with higher risk of poor wound healing. In those patients considered to be at high risk for donor site healing complications, we chose to treat the donor site with a split-thickness skin graft, or "graft back" procedure. An additional graft is taken adjacent to the initial donor site, and meshed 4:1 to cover both donor sites at once. Out of the 17 patients who received this procedure, 1 patient had a complication from the procedure that did not require an operation, and all patients appear to have good functional and cosmetic outcomes. No patients had any graft loss or graft infection. Histologic analysis showed complete epithelialization of the back-grafted area. The graft back method converts an open wound to a covered wound and may result in decreased wound healing time, improved cosmetic outcomes, and fewer complications, particularly in patients where wound healing is a concern. Importantly, it seems to have minimal morbidity. More detailed prospective studies are needed to ensure no additional risk is incurred by this procedure.
Clinical Pearl: advantages of the scalp as a split-thickness skin graft donor site. [2020]Common challenges associated with split-thickness skin graft (STSG) donor site wounds include slow healing times and poor scar cosmesis. The technique described here improves these shortcomings by utilizing a Weck knife with adjustable thickness controls to harvest STSGs from the scalp.
Full- or Split-Thickness Skin Grafting in Scalp Surgery? Retrospective Case Series. [2020]Closure of skin defects after scalp surgery may be accomplished by grafting; either split- or full-thickness. Both methods are used in Denmark, and the optimal approach on scalp defects without exposed bone is not known. This study aimed to investigate if the two methods were equal regarding graft take as primary outcome and as secondary outcomes complications and number of outpatient visits/ number of days from surgery until the last outpatient visit for the recipient site (as a proxy for time to healing), hypothesizing that they were.
Vacuum-assisted Closure in Integration of Skin Graft Over Scalp Wounds: A Randomised Control Trial. [2022]To compare outcome of split thickness graft with and without vacuum-assisted closure over the scalp soft tissue defects in terms of graft take and complications.