Skin GraftPhase 4NCT07734519
Pelashield vs Xeroform
A Phase 4 study testing Pelashield and Xeroform in people with Skin Graft, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to compare the effects (good or bad) of a new skin graft dressing (PelashieldTM) compared to the one traditionally used (Xeroform). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Graft
- What is being tested?
- Pelashield and Xeroform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing split-thickness skin graft harvest, with a donor site sufficiently large to allow division into two comparable halves for randomized dressing application.
- Donor site located in an area amenable to standardized photography and serial appearance assessment.
- Ability to provide informed consent.
- Willingness and ability to participate in scheduled follow-up visits for donor-site assessment, including standardized photography.
- Donor-site management expected to follow the standardized study dressing protocol for the duration of the early healing period.
Who cannot join
- Inability, or anticipated inability, to reliably report pain within 1hour (or in recovery room) after surgery
- Known allergy or hypersensitivity to lidocaine, silver-containing dressings, or other components of the study dressings.
- Donor sites that are too small, irregularly shaped, or anatomically unsuitable to allow division into two comparable treatment halves.
- Pre-existing skin disease at or adjacent to the donor-site region that may affect wound healing or scar appearance
- Clinical situations in which the treating surgeon anticipates that protocol-based donor-site care cannot be maintained, including cases requiring non-standard dressings or adjunctive local therapies.
- Anticipated inability to complete follow-up assessments, including inability to obtain evaluable standardized photographs at key time points.
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- Severe uncontrolled systemic conditions likely to significantly impair wound healing, at the discretion of the investigator (e.g., severe immunosuppression or other conditions making reliable donor-site healing unlikely).
- Allergy to any local anesthetic
- Allergy or sensitivity to silver
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
D'Ann Hershel, 336-716-1659, dann.hershel@advocatehealth.org
About this study
Official title: A Prospective Randomized Split-Site Study of Donor-Site Pain and Appearance Following Pelashield TM Versus Xeroform
The purpose of this research study is to compare the effects (good or bad) of a new skin graft dressing (PelashieldTM) compared to the one traditionally used (Xeroform).
Read the detailed description
A novel dressing (Pelashield) has been developed that provides wound coverage, incorporates silver for antimicrobial activity, and contains lidocaine for local analgesia. This dressing offers the potential for improved pain control, particularly for larger donor sites, and may facilitate outpatient management. However, because the dressing includes an absorbable film, there is potential for increased irritation or altered wound healing. To rigorously evaluate this product, this prospective randomized study is being done to assess both pain control and donor-site appearance outcomes. The patient will be used as their own control and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform (standard dressing used today). Patients will be blinded to treatment allocation. Outcome assessors for photographic evaluation will be blinded to treatment assignment. In patients with multiple donor sites, one donor site judged by the surgeon to be most suitable for standardized comparison will be selected as the study donor site.
- Conditions
- Skin Graft
- Being tested
- Pelashield, Xeroform
- Keywords
- Pelashield, Xeroform, donor site pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelashieldDevice
Pelashield dressing will be applied to half of the skin graft donor site
XeroformDevice
Xeroform dressing will be applied to have of the skin graft donor site
| Study group | Role | What they receive |
|---|---|---|
| Pelashield | Experimental | Pelashield skin graft dressing Receives: Device: Pelashield |
| Xeroform | Active comparator | standard of care skin graft dressing Receives: Device: Xeroform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Measured: Hour 1
Pain Score
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Measured: Hour 4
Pain Score
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Measured: Hour 8
Pain Score
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Measured: Hour 12
Pain Score
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Measured: Hour 24
Secondary outcomes (4)
Patient and Observer Scar Assessment Scale
Patient and Observer Scar Assessment Scale (POSAS): Total score 6-60. Lower scores indicate scar characteristics more similar to normal skin; higher scores indicate poorer scar quality.
Measured: Week 4, Month 3
Erythema Index
Erythema will be measured using the Mexameter. The device generates a reading in arbitrary instrument units (AU) also referred to as index units. Total range is 0 to 999. Higher erythema index values indicate greater redness of the skin.
Measured: Month 3
Melanin Index
Melanin will be measured using the Mexameter. The device generates a reading in arbitrary instrument units (AU) also referred to as index units. Total range is 0 to 999. Higher melanin index values indicate greater concentration of melanin pigment in the skin.
Measured: Month 3
Scar Tissue Compliance
Scar tissue compliance will be measured using suction-based deformation testing (BTC-2000). Compliance will be quantified as maximum tissue displacement (mm) in response to a standardized suction pressure. Greater displacement (mm) indicates greater tissue compliance (less stiffness).
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start30 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John K. Bailey, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734519
- Sponsor's protocol ID
- IRB00147578
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Split-Site Study of Donor-Site Pain and Appearance Following Pelashield TM Versus Xeroform
- ClinicalTrials.gov ID
- NCT07734519
- Acronym / sponsor ID
- IRB00147578
- Conditions
- Skin Graft
- Keywords
- Pelashield, Xeroform, donor site pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the effects (good or bad) of a new skin graft dressing (PelashieldTM) compared to the one traditionally used (Xeroform).
Detailed description
A novel dressing (Pelashield) has been developed that provides wound coverage, incorporates silver for antimicrobial activity, and contains lidocaine for local analgesia. This dressing offers the potential for improved pain control, particularly for larger donor sites, and may facilitate outpatient management. However, because the dressing includes an absorbable film, there is potential for increased irritation or altered wound healing. To rigorously evaluate this product, this prospective randomized study is being done to assess both pain control and donor-site appearance outcomes. The patient will be used as their own control and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform (standard dressing used today). Patients will be blinded to treatment allocation. Outcome assessors for photographic evaluation will be blinded to treatment assignment. In patients with multiple donor sites, one donor site judged by the surgeon to be most suitable for standardized comparison will be selected as the study donor site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelashield | Experimental | Device: PelashieldPelashield skin graft dressing |
| Xeroform | Active comparator | Device: Xeroformstandard of care skin graft dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing split-thickness skin graft harvest, with a donor site sufficiently large to allow division into two comparable halves for randomized dressing application.
- Donor site located in an area amenable to standardized photography and serial appearance assessment.
- Ability to provide informed consent.
- Willingness and ability to participate in scheduled follow-up visits for donor-site assessment, including standardized photography.
- Donor-site management expected to follow the standardized study dressing protocol for the duration of the early healing period.
Key exclusion criteria (10 listed)
- Inability, or anticipated inability, to reliably report pain within 1hour (or in recovery room) after surgery
- Known allergy or hypersensitivity to lidocaine, silver-containing dressings, or other components of the study dressings.
- Donor sites that are too small, irregularly shaped, or anatomically unsuitable to allow division into two comparable treatment halves.
- Pre-existing skin disease at or adjacent to the donor-site region that may affect wound healing or scar appearance
- Clinical situations in which the treating surgeon anticipates that protocol-based donor-site care cannot be maintained, including cases requiring non-standard dressings or adjunctive local therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PelashieldPelashield dressing will be applied to half of the skin graft donor site | Device | Pelashield |
| XeroformXeroform dressing will be applied to have of the skin graft donor site | Device | Xeroform |
Primary outcome
Pain Score
Time frame: Hour 1
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Pain Score
Time frame: Hour 4
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Pain Score
Time frame: Hour 8
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Pain Score
Time frame: Hour 12
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
Pain Score
Time frame: Hour 24
The patient will serve as their own control and and will report the comparative pain of one half of the donor site treated with Pelashield versus the half of the donor site treated only with Xeroform. Visual analog pain scale will be used with total score range of 0-10 with "0" being no pain and "10" being the absolute worst pain imaginable.
4 secondary outcomes
Patient and Observer Scar Assessment Scale
Time frame: Week 4, Month 3
Erythema Index
Time frame: Month 3
Melanin Index
Time frame: Month 3
Scar Tissue Compliance
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John K. Bailey, MD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pelashield and Xeroform in people with Skin Graft, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact D'Ann Hershel (336-716-1659, dann.hershel@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: Hour 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.