Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634030
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Evaluating RhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 faceneck 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None