About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Pelashield
Device
Pelashield dressing will be applied to half of the skin graft donor site
Xeroform
Device
Xeroform dressing will be applied to have of the skin graft donor site

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: PelashieldExperimental treatment 1 intervention

Group B: XeroformActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Hour 1

2

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.

Time frame

Hour 4

3

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.

Time frame

Hour 8

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.

Time frame

Hour 12

Secondary outcomes

1

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.

Time frame

Week 4, Month 3

2

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.

Time frame

Month 3

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.

Time frame

Month 3

4

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).

Time frame

Month 3

Pelashield vs Xeroform

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts