Evaluating RhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction

Trial Title: Evaluating RhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction

NCT ID: NCT06634030

Condition: Wound Healing
Surgical Wound
Graft Failure

Conditions: Official terms:
Wounds and Injuries
Surgical Wound
Becaplermin

Conditions: Keywords:
Complex Surgical Defect
Skin Cancer Excision
Platelet-Derived Growth Factor
Skin Graft

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: RhPDGF-BB
Description: 0.3 mg/mL rhPDGF-BB
Arm group label: rhPDGF-BB matrix

Intervention type: Drug
Intervention name: Saline
Description: Normal saline
Arm group label: Saline matrix

Summary: Skin cancers such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma lesions that develop on the head and neck are treated by Mohs surgery or wide local excision to remove all tumor cells and preserve the normal tissue. These surgical techniques may result in large wounds requiring reconstructive surgery to restore function and aesthetics. Older, frail patients are particularly vulnerable to complications from these invasive procedures often leaving them to care for chronic wounds until a split-thickness skin graft can be placed. Recombinant human platelet-derived growth factor (rhPDGF) is a manufactured protein that signals through the PDGF receptor, PDGFRβ, to mediate inflammation, granulation, angiogenesis, and remodeling during wound healing and skin repair and is FDA-cleared for diabetic neuropathic ulcers and periodontal bone and soft tissue reconstructions. Preclinical and clinical data suggest that rhPDGF may be a viable therapeutic strategy to augment the reconstruction of these complex surgical wounds by accelerating healing and reducing the time-to-readiness for skin graft placement.

Detailed description: This Phase II clinical trial will evaluate the potential efficacy of rhPDGF-BB-enhanced wound matrix versus wound matrix saturated with normal saline to augment the reconstruction of head and neck defects that cannot approximate and heal by primary intention following skin cancer excision. This prospective, double-blinded, single-site study will randomize participants into two arms - intervention and control - comparing the granulation rates of the wound bed, skin graft success, aesthetic outcomes, and quality of life. After recruiting, consenting, and screening, participants will be scheduled for the baseline procedure to place the wound matrix into the wound bed. Randomization will occur the day of the procedure, and both the investigator and participant will be blinded. To achieve balance in treatment allocation, randomization blocks of 4 (2 interventions : 2 controls) will be stratified by anatomical location, scalp versus face/neck, and greatest dimension, < or = 3cm versus > 3cm, of the surgical defect. Following the baseline procedure, participants will return for their first follow-up visit on day six for a clinical examination, suture removal, and wound dressing change, and follow-up visits will occur weekly for 8 weeks thereafter. At each visit, participants will complete the VAS pain scale and discuss any adverse events, the wound will be photographed and examined, and the investigator will assess the percent granulation and readiness for a skin graft. Participants will also submit daily photos of the wound while performing dressing changes at home starting on day seven until the skin graft procedure is completed. These photographs will be taken using a wound imaging application capable of ensuring a quality image, measuring the area of the wound, and transfer of the images to password-protected, cloud-based storage. The images will be analyzed by blinded wound experts, retrospectively, to determine the precise day (rather than the week) that the wound bed achieved 95-100% granulation. Placement of the skin graft may occur anytime between the first follow-up visit 1 week after the baseline procedure through 8 weeks. After the skin graft is placed, participants will continue the weekly visits through 8 weeks following the baseline procedure to assess pain and graft take. Under routine care with a wound matrix (no rhPDGF-BB), the average time to readiness is 4-6 weeks in this patient population. Here, we aim to reduce the time to readiness by adding rhPDGF-BB.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Underwent surgery to completely remove skin cancer, either Mohs micrographic or wide local excision, that left a full-thickness surgical defect of the head or neck measuring between 1.5-10cm in greatest dimension with clear margins as assessed in the pathology report. - Margins of the wound cannot be approximated or closed with stitches, sutures, staples, or glue - Surgeon does not plan for immediate skin graft or flap - Aged >21 years old - Willing and able to provide informed consent for study participation and compliance with study protocol - Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: - Medical conditions that would, in the opinion of the Investigator or treating provider, compromise the safety of the individual with study participation and/or the ability of the individual to follow study protocol - The device will not fit the contour of the base of the wound bed - Evidence of current clinical infection as demonstrated by the invasion of bacteria into the healthy viable tissue on the periphery of the wound (colonization of wound bed due to normal flora or environment is not exclusionary) - Prior radiation therapy at the application site - Known allergic reactions to porcine tissue, porcine collagen, or yeast-derived products - Currently enrolled in a drug or device trial or within 30 days of last investigational drug or device administration at baseline visit where investigational treatment (drug or device) was placed in wound bed or may potentially interact with study treatment - Women who are pregnant, breastfeeding, or planning to become pregnant during the trial

Gender: All

Minimum age: 22 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Vanderbilt University Medical Center

Address:
City: Nashville
Zip: 37203
Country: United States

Start date: November 2024

Completion date: February 2026

Lead sponsor:
Agency: Wesley Thayer
Agency class: Other

Collaborator:
Agency: Lynch Regenerative Medicine, LLC
Agency class: Other

Source: Vanderbilt University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06634030