rhPDGF-BB for Healing Surgical Wounds in Head and Neck
Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction
Recruiting
Phase 2
Interventional Study
Wound Healing
Surgical Wound
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for adults who have had surgery to remove skin cancer from their head or neck, which left a large wound that cannot be stitched closed. Participants will receive a treatment to help the wound heal better and faster.
Are You a Good Fit for This Trial?
You may be able to join if
- I have had surgery to remove skin cancer from my head or neck.
- My surgical wound is between 1.5-10 cm in size.
- My doctor does not plan for immediate skin graft or flap.
- I am over 21 years old.
- I can give my consent to participate in this study.
- I am willing to follow all study procedures.
- I am available for the duration of the study.
You may not be able to join if
- I have medical conditions that may affect my safety in this trial.
- The treatment device will not fit the shape of my wound.
- I currently have an infection in my wound.
- I have had radiation therapy at the site of my wound.
- I am allergic to porcine tissue, porcine collagen, or yeast products.
- I am currently enrolled in another drug or device trial.
- I am pregnant, breastfeeding, or planning to become pregnant during the trial.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 techn…
Trial Locations
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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.
* Margin…
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