[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07734519":3,"trial-entities:NCT07734519":116,"trial-summary:NCT07734519":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":39,"secondary_outcomes":52,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":89,"locations":92,"central_contacts":108,"overall_officials":110,"references":114,"see_also_links":115},"NCT07734519","IRB00147578","Pelashield vs Xeroform","A Prospective Randomized Split-Site Study of Donor-Site Pain and Appearance Following Pelashield TM Versus Xeroform","NOT_YET_RECRUITING","2027-07","2026-07","2026-07-31","2026-08","Wake Forest University Health Sciences","OTHER",false,"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).","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.",[19],"Skin Graft",[21,22,23],"Pelashield","Xeroform","donor site pain","INTERVENTIONAL","TREATMENT",[27],"PHASE4",{"count":29,"type":30},40,"ESTIMATED",[32,36],{"type":33,"name":21,"description":34,"armGroupLabels":35},"DEVICE","Pelashield dressing will be applied to half of the skin graft donor site",[21],{"type":33,"name":22,"description":37,"armGroupLabels":38},"Xeroform dressing will be applied to have of the skin graft donor site",[22],[40,44,46,48,50],{"measure":41,"description":42,"timeFrame":43},"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.","Hour 1",{"measure":41,"description":42,"timeFrame":45},"Hour 4",{"measure":41,"description":42,"timeFrame":47},"Hour 8",{"measure":41,"description":42,"timeFrame":49},"Hour 12",{"measure":41,"description":42,"timeFrame":51},"Hour 24",[53,57,61,64],{"measure":54,"description":55,"timeFrame":56},"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.","Week 4, Month 3",{"measure":58,"description":59,"timeFrame":60},"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.","Month 3",{"measure":62,"description":63,"timeFrame":60},"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.",{"measure":65,"description":66,"timeFrame":60},"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).","ALL","18 Years",null,{"inclusion":71,"exclusion":77,"raw_text":88},[72,73,74,75,76],"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.",[78,79,80,81,82,83,84,85,86,87],"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.","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","Inclusion Criteria:\n\n* Undergoing split-thickness skin graft harvest, with a donor site sufficiently large to allow division into two comparable halves for randomized dressing application.\n* Donor site located in an area amenable to standardized photography and serial appearance assessment.\n* Ability to provide informed consent.\n* Willingness and ability to participate in scheduled follow-up visits for donor-site assessment, including standardized photography.\n* Donor-site management expected to follow the standardized study dressing protocol for the duration of the early healing period.\n\nExclusion Criteria:\n\n* Inability, or anticipated inability, to reliably report pain within 1hour (or in recovery room) after surgery\n* Known allergy or hypersensitivity to lidocaine, silver-containing dressings, or other components of the study dressings.\n* Donor sites that are too small, irregularly shaped, or anatomically unsuitable to allow division into two comparable treatment halves.\n* Pre-existing skin disease at or adjacent to the donor-site region that may affect wound healing or scar appearance\n* 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.\n* Anticipated inability to complete follow-up assessments, including inability to obtain evaluable standardized photographs at key time points.\n* 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).\n* Allergy to any local anesthetic\n* Allergy or sensitivity to silver\n* Pregnancy",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":94,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":105},"Atrium Health Wake Forest Baptist","Winston-Salem","North Carolina","27157","United States",[100],{"name":101,"role":102,"phone":103,"email":104},"D'Ann Hershel","CONTACT","336-716-1659","dann.hershel@advocatehealth.org",{"lat":106,"lon":107},36.09986,-80.24422,[109],{"name":101,"role":102,"phone":103,"email":104},[111],{"name":112,"affiliation":94,"role":113},"John K. Bailey, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":117,"biomarkers":119},[118],"Skin Transplantation",[],{"nct_id":4,"found":121,"summary":122,"prompt_version":132},true,{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is a randomized study where you will be your own control. Half of your skin graft donor site will receive Pelashield and the other half will receive Xeroform, and you won't know which is which.","completed","Comparing Pelashield and Xeroform Dressings for Skin Grafts","This study is comparing a new skin graft dressing called Pelashield to a standard dressing called Xeroform. If you are having a split-thickness skin graft (where a thin layer of skin is taken from one area to cover another), and your donor site (where the skin is taken from) is large enough, you might be able to join. The study wants to see if Pelashield helps with pain better and how it affects the appearance of the donor site compared to Xeroform. Researchers will measure your pain at 1, 4, and 8 hours after the dressing is applied. The study plans to enroll 40 people, but its current status is unclear.","Pain will be measured at 1, 4, and 8 hours after dressing application.",111,"Not specified in the trial record.","Not stated in the trial record.",[21,22],"v2"]