A Phase 3 interventional study of NovaDress and Mepilex Ag in Donor Sites, Wound Heal and Wound Drainage, sponsored by Joseph M. Still Research Foundation, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by Joseph M. Still Research Foundation, Inc. · Phase 3, Interventional, and Treatment
This is a three arm study, comparing the Novadress, Mepilex Ag, and Xeroform Occlusive dressings for healing, drainage, and pain management. NovaDress is constructed of pure cellulose derived from tree pulp. Mepilex Ag is a antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment. Xeroform Occlusive Dressing is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 93 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Joseph M. Still Research Foundation, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
patient will receive Mepilex Ag for their site, standard of care to be followed.
Device: Mepilex Ag
patient will receive Xeroform for their site, standard of care to be followed.
Device: Xeroform
patient will receive NovaDress for their site, standard of care to be followed.
Device: NovaDress
NovaDress is constructed of pure cellulose derived from tree pulp. The tree pulp is reconstructed into hydrated sheets wrapped in nonwoven viscose and irradiated.
Mepilex Ag is an antimicrobial foam dressing that absorbs low to moderate exudate and maintains a moist wound environment.
Xeroform® Occlusive Dressing (XF) is a fine-mesh gauze impregnated with a petrolatum blend, 3% bismuth tribromophenate.
Pain and Healing
To compare and healing (defined as \>95% epithelization) at the study donor sites treated with a cellulose dressing to two standard of care dressings- an antimicrobial foam dressing and a bacteriostatic petrolatum based gauze dressing.
Time frame: 14 days
Absorbent ability
Ability of dressing to absorb exudate measured by staff satisfaction survey
Time frame: 14 days
Conformability
Ability of dressing to maintain shape measured by staff satisfaction survey
Time frame: 14 days
Adherence
Ability of dressing to remain fixed in place measured by staff satisfaction survey
Time frame: 14 days
Management of bloody exudate
Ability of dressing to absorb bloody exudate measured by staff satisfaction survey
Time frame: 14 days
Ease of removal
Ability of dressing to be removed in an atraumatic fashion measured by staff satisfaction survey
Time frame: 14 days
Cost
Average cost incurred by the patient for donor site dressings measured by staff satisfaction survey
Time frame: 14 days
Plan to share: No
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Joseph M. Still Research Foundation, Inc.