Pinch Grafting for Scalp Wounds

Overseen By John Robb, BS, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Incarceration, Pregnant, Bone exposure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which scalp wound healing method is more effective: natural healing (second intention) or using a pinch graft. A pinch graft involves taking a small piece of skin from one part of the body and placing it on the wound to speed up healing. Candidates for this trial include those planning scalp surgery who expect natural healing and are willing to attend follow-ups and provide weekly updates about their wound. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future scalp wound healing methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the pinch graft technique is safe for scalp wounds?

Research has shown that pinch grafting is a safe and effective method for healing wounds. Most patients tolerate it well, according to studies. Although minor issues can occur, they are rare in adults. The process involves taking a thin piece of skin, usually from the groin, and placing it on the wound. This promotes new skin growth and accelerates healing. Overall, pinch grafting is considered a safe option for treating scalp wounds. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Pinch grafting is unique because it offers a new method for healing scalp wounds, especially when compared to the standard of care, which often involves secondary intention healing or more invasive grafting techniques. Researchers are excited about this technique because it potentially provides faster healing and improved cosmetic outcomes by using small skin grafts taken from the patient's own body. This method can be less invasive, reduce recovery time, and minimize the risk of complications associated with larger grafts or surgical intervention.

What evidence suggests that the pinch graft technique is effective for scalp wound healing?

Research has shown that pinch grafting, a treatment under study in this trial, can accelerate wound healing. In one study, wounds treated with pinch grafts healed completely in just 14 days, much faster than the natural healing process used in the other arm of this trial, which can take 8 weeks or more. Another study found that 90% of patients experienced successful results without complications. The pinch graft method involves taking a small piece of skin from another part of the body and placing it on the wound, promoting the rapid growth of new, healthy skin. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel Eisen, MD

Principal Investigator

University of California, Davis - Dermatology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for a skin surgery on my scalp that will heal without stitches.

Able to give informed consent themselves

Willing to return for follow up visit

Exclusion Criteria

Incarceration

Pregnant women

I cannot understand written or spoken English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either pinch grafting or second intention wound healing for Mohs micrographic surgery defects on the scalp

1-8 weeks

Weekly photo submissions

Follow-up

Participants are monitored for scar assessment and healing outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Pinch Graft

Trial Overview 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.

How Is the Trial Designed?

Group I: Pinch Grafting Experimental Treatment 1 Intervention

Group II: Second Intention Wound Healing Active Control 1 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

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

A study involving 43 children aged 9 months to 15 years demonstrated that harvesting skin grafts from the scalp is effective, with a mean healing time of 9.5 days and no reported infections or significant complications.

The method is recommended as a first choice for skin grafting due to its advantages, including rapid healing and minimal scarring, despite some cases of alopecia and minor complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin harvesting on the scalp in children: utopia or reality. Gyger, D., Genin, B., Bugmann, P., et al.[2004]

The use of a Weck knife with adjustable thickness controls for harvesting split-thickness skin grafts (STSGs) from the scalp can enhance healing times and improve the cosmetic appearance of donor site wounds.

This technique addresses common issues associated with STSG donor sites, potentially leading to better patient outcomes in terms of recovery and scar quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Pearl: advantages of the scalp as a split-thickness skin graft donor site. Croley, JAA., Hirshburg, JM., Wagner, RF.[2020]

In a study involving 26 patients, the scalp was found to be an excellent source for split thickness skin grafts, demonstrating rapid healing and a low risk of infection.

The regrowth of hair at the donor site helps to conceal any visible scars, making scalp grafts a favorable option for skin graft procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scalp as a donor site. Taylor, JW., Wilmore, DW., Peterson, HD., et al.[2019]

In a review of 113 patients undergoing 178 scalp split-thickness skin graft procedures, minor complications were noted in adults, confirming previous research.

However, in pediatric patients, the large surface area of the scalp can lead to excessive blood loss, making it a less favorable donor site for skin grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of scalp split-thickness skin grafts and potential complications. Lesesne, CB., Rosenthal, R.[2019]

Small split-thickness skin grafts, or pinch grafts, are an effective treatment for stubborn skin ulcers, helping to promote healing.

Combining new surgical dressings with traditional pinch grafting techniques can enhance graft survival and speed up the formation of granulation tissue in clean ulcer bases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The technique and current status of pinch grafting. Wheeland, RG.[2019]

In a study of 106 patients who underwent scalp surgery, both full-thickness skin grafts (FTSG) and split-thickness skin grafts (STSG) showed similar rates of graft adherence and complications, indicating that both methods are equally effective for closing scalp defects.

There was no significant difference in the number of outpatient visits or the time to healing between the two graft types, suggesting that either option can be safely used without impacting recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full- or Split-Thickness Skin Grafting in Scalp Surgery? Retrospective Case Series. Hilton, CMH., Hölmich, LR.[2020]

The new slit grafting technique allows for the effective treatment of thinning scalp hair by using miniature grafts from 'serrated islands' and single-hair grafts, providing a versatile solution for both early and advanced hair loss.

This method can be used in various scenarios, including repair work and extensive coverage, and it promotes natural-looking hair growth by placing hundreds of grafts in small slits, making it suitable for patients with different hair and skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slit grafting: the use of serrated island grafts in male and female-pattern alopecia. Swinehart, JM., Griffin, EI.[2019]

In a study of 13 patients, auto-scalp grafting successfully repaired donor sites from cicatricial skin, with all grafts surviving and a significantly shorter average healing time of 7 days compared to 20 days in the control group.

After 12 months, the auto-scalp grafting group showed significantly better outcomes in scar formation, itchiness, and proliferation rates, indicating improved quality of healing compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study of repairing donor site of thickness from cicatricial skin with auto-scalp grafting]. Shen, CA., Chai, JK., Zhang, L., et al.[2013]

The 'graft back' procedure, which involves using a split-thickness skin graft to cover the donor site, was performed on 17 patients at high risk for delayed wound healing, resulting in good functional and cosmetic outcomes with minimal complications.

Histologic analysis confirmed complete healing of the grafted area, suggesting that this method may reduce healing time and complications compared to traditional healing methods, although further studies are needed to assess long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Back Grafting the Split-Thickness Skin Graft Donor Site. Goverman, J., Kraft, CT., Fagan, S., et al.[2018]

In a randomized controlled trial involving 120 patients with scalp soft tissue defects, the use of vacuum-assisted closure (VAC) dressing significantly improved graft take rates, with 93.3% success in the VAC group compared to only 40.0% in the simple dressing group.

The VAC dressing also resulted in fewer complications, including lower rates of seroma (1.67% vs. 13.3%), hematoma (0.0% vs. 6.67%), and graft edge dehiscence (0.0% vs. 5.0%), indicating a safer and more effective approach for managing split thickness skin grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-assisted Closure in Integration of Skin Graft Over Scalp Wounds: A Randomised Control Trial. Mujahid, AM., Khalid, FA., Ali, N., et al.[2022]

In a study of 295 burn patients, harvesting thin split-skin grafts (0.005-0.007 in.) from the scalp was found to be a safe procedure, with no cases of hypertrophic scarring or keloids reported.

The average time for the donor site to heal (epithelization) was 7 days, and only a small percentage (1.82%) experienced folliculitis, indicating minimal complications associated with this grafting technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absence of pathological scarring in the donor site of the scalp in burns: an analysis of 295 cases. Farina, JA., Freitas, FA., Ungarelli, LF., et al.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10917469/

Utilization of Split-Thickness Skin Graft as a Treatment Option ... This study explores the use of STSG employing the pinch graft technique for hard-to-heal surgical wounds following Mohs micrographic surgery (MMS).

2. sciencedirect.com sciencedirect.com/science/article/pii/S0305417924003267

Advancements in skin grafting This investigation delineates the evolution and prospective utilisation of an innovative two-blade dermatome, designed for the concurrent harvesting of a ...

3. liebertpub.com liebertpub.com/doi/10.1089/wound.2023.0020

Split-Thickness Skin and Dermal Pixel Grafts Can Be ... Results: The validation study showed that when STS and dermal PGs were transplanted in a 1:2 ratio they fully re-epithelialized the wounds in 14 days. The ...

4. mdpi.com mdpi.com/1648-9144/57/4/348

Historical Evolution of Skin Grafting—A Journey through Time Full-thickness skin grafting achieves the best aesthetic and functional results in burn injury reconstruction [3,4,5]. The origin of skin ...

5. researchgate.net researchgate.net/publication/374120724_Enhancing_Lower_Extremity_Defect_Coverage_High_Viability_Ultra-Thin_Split-Thickness_Skin_Grafts_Obtained_from_the_Scalp

High Viability Ultra-Thin Split-Thickness Skin Grafts ... A substantial majority of patients (90%) achieved successful graft take with no complications. Swift re-epithelialization occurred within a ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38630594/

Pinch Grafting: A Systematic Review of Modern ... Pinch grafting is a safe, straightforward, and effective technique to promote the healing of chronic wounds.

7. withpower.com withpower.com/trial/phase-cicatrix-2-2024-e2e8e

Pinch Grafting for Scalp Wounds Pinch grafting, also known as split-thickness skin grafting, is generally safe for humans, with minor complications in adults. However, in children, there ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6790251/

Full- or Split-Thickness Skin Grafting in Scalp Surgery? ... 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 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0365059624000333

Special Article Follicular unit grafting in chronic ulcers The technique of follicular unit auto-grafting obtained from the scalp punch is among the chosen strategies for the management of recalcitrant ulcers.

10. sciencedirect.com sciencedirect.com/topics/engineering/thickness-skin-graft

Thickness Skin Graft - an overview Full-thickness grafting is preferable for most wounds in children, given that the grafts will grow with the growing child and reduce the risk of scar ...