RECELL® for Head and Neck Cancer Reconstruction

(RECOLOR-HN Trial)

This trial tests a new method to improve skin color matching after reconstructive surgery for head and neck cancer. Researchers aim to determine if using RECELL®—a device that prepares skin cells for grafting—on de-epithelialized tissue leads to better color and healing than standard skin grafting. All participants will receive the same treatment, and their results will be compared. The trial seeks individuals with a skin defect on the head or neck requiring reconstruction and who are eligible for surgery. As an unphased trial, this study offers a chance to contribute to innovative research that could enhance future reconstructive surgery outcomes.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that RECELL is generally safe for skin treatments. In one study, 92% of wounds treated with RECELL healed within 8 weeks, comparable to traditional methods. The FDA has approved RECELL for treating burn wounds, confirming it meets safety standards.

Another study found that combining RECELL with traditional skin grafting resulted in fewer complications than grafting alone. This suggests patients may tolerate RECELL well. Common side effects, such as pain and scarring, are expected and similar to those with standard skin treatments.

Unlike the standard treatments for head and neck cutaneous defects, which typically involve split-thickness skin grafts or de-epithelialized tissue alone, RECELL® introduces a new approach by using autologous skin cell suspension (ASCS). This method allows for the application of a patient's own skin cells directly onto the wound, potentially enhancing healing and reducing scarring. Researchers are excited because RECELL® may offer a more natural and efficient way to reconstruct skin, potentially improving outcomes and recovery times compared to traditional grafting techniques.

Research has shown that RECELL® can help skin heal and match its original color. Studies have found that using RECELL® for skin repair achieves similar healing results to traditional skin grafts but requires less donor skin. In treating burns, RECELL® has been associated with fewer complications when combined with split-thickness skin grafts, compared to using grafts alone. This method uses a mixture of the patient's own skin cells to aid healing and skin growth. Additionally, RECELL® has proven safe and effective for treating burn wounds and deep skin injuries. Positive results from these studies suggest that RECELL® might improve skin color matching in head and neck reconstruction. In this trial, participants with head and neck cutaneous defects needing skin grafting will have their defect split into three sections and closed with one of the following: split-thickness skin graft (STSG), de-epithelialized tissue alone, or de-epithelialized tissue with RECELL® ASCS. All participants will receive the same intervention and will serve as their own controls.²³⁵⁶⁷