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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06634030
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RhPDGF-BB — DRUG
    0.3 mg/mL rhPDGF-BB
  • Saline — DRUG
    Normal saline

Study Details

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 defects requiring reconstruction to restore function and aesthetics. Rotational flaps and free flaps are techniques used to reconstruct large, complex defects that cannot be closed with sutures, staples, or glue. Older, frail patients are particularly vulnerable to complications from these procedures often leaving them to care for chronic wounds until a skin graft can be placed. Phenome-wide association studies (PheWAS) revealed a cohort of patients with a single nucleotide variant (SNV) in PDGFRβ having a higher incidence of chronic skin ulcers, skin grafts, and other skin and connective tissue disorders suggesting that the loss of PDGFβ signaling may impair healing following trauma. rhPDGF-BB, a recombinant human platelet derived growth factor protein-based therapy, signals through 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. These data suggest rhPDGF-BB may be a viable therapeutic strategy to augment the reconstruction of these complex defects by accelerating granulation, epithelialization, and wound closure.

Key Dates

Start date
Apr 1, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Saline matrix
    Participants receive wound matrix saturated with normal saline.
  • Experimental: rhPDGF-BB matrix
    Participants receive wound matrix saturated with rhPDGF-BB.

Primary Outcome Measure

Time-to-Readiness for Skin Graft in Days [ Time Frame: Daily, starting at day 7 up to day 56 following the baseline procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37203-

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Vanderbilt University Medical Center· Nashville, TN

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