Clinical trial NCT06634030: Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction
Official title: A Randomized, Double-Blinded, Controlled Trial Evaluating Recombinant Human Platelet-Derived Growth Factor B (rhPDGF-BB)-Enhanced Wound Matrix in the Reconstruction of Full-Thickness Head or Neck Defects Following Skin Cancer Excision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Wound Healing
Surgical Wound
Graft Failure
Keywords: Complex Surgical Defect
Skin Cancer Excision
Platelet-Derived Growth Factor
Skin Graft
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Lynch Regenerative Medicine, LLC
First posted: 2024-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Time-to-Readiness for Skin Graft in Days
timeFrame: Daily, starting at day 7 up to day 56 following the baseline procedure
Secondary outcomes:
measure: Granulation Rate
timeFrame: Daily, starting at day 7 up to day 56 following the baseline procedure
measure: Change in Granulation on a 5-Point Scale
timeFrame: Weekly, starting at week 1 up to week 8 following the baseline procedure
measure: Time-to-Readiness for Skin Graft in Weeks
timeFrame: Weekly, starting at week 1 up to week 8 following the baseline procedure
measure: Time to Skin Graft in Days
timeFrame: From day 7 up to day 566 following the baseline procedure
measure: Percentage of Skin Graft Take
timeFrame: Week 1 following skin graft placement
measure: Aesthetics Rating at Week 8
timeFrame: Week 8
measure: Scar Scale at Week 8
timeFrame: Week 8
measure: Change from Baseline in Pain on an 11-Point Scale
timeFrame: From enrollment through week 8
measure: Change from Baseline in Quality of Life
timeFrame: From enrollment through week 8
measure: Number of Participants Recruited and Eligible
timeFrame: Monthly up to month 15
measure: Number of Participants Randomized Per Month
timeFrame: Monthly up to month 15
measure: Proportion of Participants Retained at Week 8
timeFrame: Week 8
measure: Weekly Percentage of Completed Daily Photos at Week 8
timeFrame: Weekly, week 1 up to week 8
measure: Concordance of Time-to-Readiness Between Photograph Assessments versus Clinical Exams
timeFrame: Weekly, week 1 up to week 8
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Wesley P Thayer
role: PRINCIPAL_INVESTIGATOR
References: