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

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.

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 data supports the effectiveness of the treatment Pinch Grafting for Scalp Wounds?

Pinch grafting, which involves using small pieces of skin to help heal wounds, has been shown to be effective for stubborn skin ulcers by improving healing time and graft survival. This suggests it could also be beneficial for scalp wounds. ^{1 2 3 4 5}

Is pinch grafting for scalp wounds safe for humans?

Pinch grafting, also known as split-thickness skin grafting, is generally safe for humans, with minor complications in adults. However, in children, there can be issues like excessive blood loss due to the large surface area of the scalp. Overall, the procedure has minimal risk, especially in healthy individuals, but those with healing challenges may need special care. ^{3 6 7 8 9}

How is pinch grafting different from other treatments for scalp wounds?

Pinch grafting is unique because it uses small pieces of the patient's own skin to cover scalp wounds, promoting faster healing and better graft survival when combined with new surgical dressings. Unlike other methods, it takes advantage of the scalp as a donor site, which heals quickly and is less prone to infection, with hair regrowth concealing the donor area. ^{1 2 5 10 11}

Research Team

Daniel Eisen, MD

Principal Investigator

University of California, Davis - Dermatology

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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 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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Pakistan pubmed.ncbi.nlm.nih.gov

Vacuum-assisted Closure in Integration of Skin Graft Over Scalp Wounds: A Randomised Control Trial. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

Full- or Split-Thickness Skin Grafting in Scalp Surgery? Retrospective Case Series. [2020]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical study of repairing donor site of thickness from cicatricial skin with auto-scalp grafting]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Pearl: advantages of the scalp as a split-thickness skin graft donor site. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A review of scalp split-thickness skin grafts and potential complications. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Absence of pathological scarring in the donor site of the scalp in burns: an analysis of 295 cases. [2010]

8. England pubmed.ncbi.nlm.nih.gov

Back Grafting the Split-Thickness Skin Graft Donor Site. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Skin harvesting on the scalp in children: utopia or reality. [2004]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Scalp as a donor site. [2019]