Pelashield for Skin Grafting
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new skin graft dressing called Pelashield, comparing it to the traditional dressing, Xeroform. The goal is to determine Pelashield's effectiveness in healing and comfort after skin graft surgery. Candidates for participation include those needing a skin graft with a donor site that can be divided into two parts for testing. Participants must attend follow-up visits and allow photographs of the healing process. As a Phase 4 trial, Pelashield has already received FDA approval and proven effective; this research aims to understand its benefits for more patients.
What is the safety track record for these treatments?
Research shows that Pelashield, a new type of skin dressing, has passed important safety tests and is considered safe to use. Earlier studies did not identify any major safety concerns with Pelashield. The FDA has approved it for treating wounds, indicating it meets high safety standards. Although specific study details are not provided here, available evidence suggests that Pelashield is generally well-tolerated by patients and usually does not cause serious side effects.12345
Why are researchers enthusiastic about this study treatment?
Pelashield is unique because it offers a new approach to skin graft dressing by potentially enhancing healing and protection more effectively than traditional options like Xeroform. Unlike Xeroform, which is a standard care dressing, Pelashield might provide better moisture management and antimicrobial protection, crucial for optimal skin graft healing. Researchers are excited about Pelashield because it could lead to faster recovery times and improved outcomes for patients undergoing skin grafts.
What evidence suggests that this trial's treatments could be effective for skin grafting?
This trial will compare Pelashield, an experimental skin graft dressing, with Xeroform, the standard care dressing. Studies have shown that Pelashield, a type of skin graft covering, might help wounds heal more effectively. It contains silver to prevent infections and a pain reliever for comfort. Research indicates that skin grafts using Pelashield have a high success rate, with some studies showing rates as high as 91.76%. The dressing has passed safety tests, confirming its safety for use. These features suggest that Pelashield could be a promising option for improving skin graft results.16789
Who Is on the Research Team?
John K. Bailey, MD
Principal Investigator
Atrium Health Wake Forest Baptist
Are You a Good Fit for This Trial?
This trial is for people who need skin grafts. Specific inclusion and exclusion criteria are not listed, so eligibility may depend on the type of wound or other health factors determined by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Pelashield or Xeroform dressing on donor sites to compare pain control and appearance outcomes
Follow-up
Participants are monitored for scar assessment and skin indices
What Are the Treatments Tested in This Trial?
Interventions
- Pelashield
- Xeroform
Trial Overview
The study compares two dressings used after skin graft surgery: a new dressing called Pelashield and a traditional one called Xeroform, to see which works better or has fewer problems.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Pelashield skin graft dressing
standard of care skin graft dressing
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Citations
Comparing the Curative Efficacy of Different Skin Grafting ...
After surgery, the majority of all skin grafts in the three groups survived. The skin graft survival rate of the Meek group even reached 91.76%, and such a ...
2.
hmpgloballearningnetwork.com
hmpgloballearningnetwork.com/site/wounds/case-series/reduced-time-skin-grafting-chronic-wounds-using-esterified-hyaluronic-acidReduced Time to Skin Grafting in Chronic Wounds Using ...
Results. The average time to closure was similar between group 1 and group 2 (15.2 weeks vs 14.6 weeks) despite a nearly twofold greater initial wound area.
Minced skin graft's cost effectiveness
If less than a 50% reduction occurs, it is unlikely to heal on this treatment and change of treatment should be considered (Kantor and Margolis, ...
Healing and Cosmetic Outcomes in Split-Thickness Skin ...
Mean cosmetic outcome score was 3.08 ± 1.72 with standard dressing and 0.78 ± 0.56 with graft paste at three-month follow-up. Conclusion: Minced skin grafting ...
Pelashield™ PainGuard™ vs Restrata® in HS Surgery
PelashieldTM PainGuardTM contains antimicrobial silver and local anesthetic, which may reduce postoperative pain and infection compared to Restrata®,
A novel engineered skin closes full thickness burn wounds
The take rate of the grafted PG-HSE was 95% at 2 weeks post-grafting, with no wound breakdown or requirement for further surgery at the PG-HSE graft sites at 15 ...
References
The results indicate that the subject device passed toxicity and safety tests and is safe for intended use. Data on file in the 510k application.
Pelashield PainGuard for Hidradenitis Suppurativa
PelashieldTM PainGuardTM is already deemed safe enough to test for effectiveness in this context. Current knowledge suggests no major safety concerns.
9.
providerpublic.mybcbswny.com
providerpublic.mybcbswny.com/medpolicies/wellpoint/active/gl_pw_e003574.htmlCG-SURG-127 Products for Wound Healing and Soft ...
An acellular bovine dermis product that been cleared through the FDA's 510K process for the management of wounds that include partial and full ...
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