Percentage wound area reduction over time [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The percentage of wound area (cm2) reduction over time will be assessed by a formula as the area of an ellipse and measured by an independent evaluator assisted by digital software on all digital photographs taken at each scheduled visit.
Percentage wound volume reduction over time (DFUs only) [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The percentage wound volume (cm3) reduction over time will be calculated by a formula from the manually assessed wound depth and the digitally assessed wound area.
Linear wound healing over time [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The linear wound healing will be calculated with Gilman’s formula (cm/day), G = – (A1-A0)/ {[(P1+P0)/2]*(t1-t0)}, where:
A0 = previous visit area A1 = current visit area P0 = previous visit perimeter P1 = current visit perimeter t0 = previous visit time t1 = current visit time.
Area (A) and Perimeter (P) will be assessed by an independent evaluator assisted by digital software. Perimeter (P) will be measured in cm and Area (A) will be assessed in cm2.
Change in granulation tissue over time [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The area of wound covered by granulation tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
Change in sloughy tissue over time [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The area of wound covered by sloughy tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
Change in exudate amount over time [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Exudate amount will be captured as a subjective measure from the investigator/designee and assessed as none, scant, small, moderate, or large.
Change in exudate nature over time [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Exudate nature will be captured as a subjective measure from the investigator/designee via the following category descriptive scale: serous, serosanguinous, sanguineous, seropurulent, fibrinous, purulent, hemopurulent, or hemorrhagic.
Change in peri-wound skin condition over time [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The change in peri-wound skin condition over time will be assessed by visual assessment (No/Yes) by investigator/designee for maceration, dry skin, erythema/redness, and other peri-wound skin conditions. The Transepidermal Water Loss, or TEWL, will be an additional variable assessed at every visit for VLU Subjects at a limited number of clinical sites. TEWL measurements will be done using a portable VapoMeter.
Change in maceration over time [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Area of wound covered by macerated tissue (%) will be assessed before debridement in cm2 by an independent evaluator assisted by digital software.
The maximal distance (cm) from as close to the wound edge as possible to the end of maceration, assessed from wound photo, taken before debridement, by an independent evaluator assisted by digital software. The area of maceration will be assessed from a wound photo taken before debridement by an independent evaluator assisted by digital software.
Wound/Peri-Wound itch score prior to dressing removal over time (PRO) [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The Subject itch severity before dressing removal over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates their level of itchiness on a level from 0 to 10, where 0 indicates no itch and 10 is the worst itch.
Wound pain score during dressing wear over time (PRO) [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Subject pain severity during dressing wear over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain.
Wound pain score related to removal of dressing over time (PRO) [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Subject pain severity at dressing removal will be assessed at all follow-up visits using the NRS scale where the Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain. Any pre-procedural or intra-procedural pain medication administered at the time of dressing removal will be recorded.
Trauma to the wound/peri-wound during dressing removal over time [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Trauma to the wound will be captured via visual judgement by the investigator/desginee using an ordinal scale of none, very slight, moderate, or high. Trauma to the peri-wound skin will be captured via visual judgement by the investigator/designee using the ordinal scale of none, very slight, moderate, or high.
Primary dressing’s ability to be comfortable to wear (PRO) [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Subjects will be asked to rate Mepilex Up degree of comfort using a 4-item scale of very poor, poor, good, or very good.
For VLU: Mepilex Up ability to be comfortable to wear with compression (PRO) [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
VLU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with compression using a 4-item scale of very poor, poor, good, or very good.
For DFU: Mepilex Up ability to be comfortable to wear with offloading (PRO) [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
DFU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with offloading using a 4-item scale of very poor, poor, good, or very good.
Evaluation of Wound Quality of Life (QoL) (PRO) [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
A Wound-QoL-17 questionnaire will be completed by each Subject to measure the disease-specific, health-related QoL of those with chronic wounds. All items assess impairments within the preceding seven days.
Technical Performance (Investigator/designee’s evaluation) [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Several questions will be asked to evaluate the technical performance properties of Mepilex Up. The following will be assessed by the investigator/designee using no/yes values: 1) Occurrence of strike-through, defined as the inability of the dressing to stay sealed over the wound causing leakage of wound exudate; and 2) Occurrence of product residue in the wound bed or on peri-wound skin after dressing removal. All other properties will be assessed by the investigator/designee using a 4-item scale of very poor, poor, good, very good. These include:
Ability to absorb exudates with different viscosities,
Ability to retain exudate,
Ease of application,
Ability to conform to the wound during wear,
Ability to be repositioned during application,
Inability to adhere to moist wound bed,
Ability to adhere to healthy, intact skin,
Ability to stay on during application and use,
Overall satisfaction with the dressing’s properties.
Status of dressing during a routine dressing change or complication [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The status of Mepilex Up during a routine dressing change or complication will be assessed by the investigator/designee as strike-through, saturated, displaced/slipping, or other. This will be recorded in the Dressing Log.
Pre-compression edema [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The specification of any pre-compression edema prior to applying/changing compression therapy will be assessed by the investigator/designee as:
0 (no clinical edema)
1+ (≤2 mm indentation)
2+ (2-4 mm indentation)
3+ (4-6 mm indentation)
4+ (6-8 mm indentation)
Compression removed/changed/applied [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Assessment of compression by the investigator/designee will cover:
Compression removal (No/Yes)
Compression changed/applied (No/Yes)
Type of compression used
Compliance with compression [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The investigator/designee will evaluate Subject compliance with compression. Assessment will include being fully compliant (defined as 7 out of 7 days with compression), moderately compliant (defined as 1 to 3 days without compression out of 7 days), or not compliant (defined as >3 days without compression out of 7 days).
Offloading Use/Type [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The assessment of offloading will cover if it were used (No/Yes) and specification of offloading type by the investigator/designee.
Compliance to offloading [ Time Frame: A maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The investigator/designee will evaluate Subject compliance with offloading. Assessment will include being fully compliant (defined as 7 out of 7 days with offloading), moderately compliant (defined as 1 to 3 days without offloading out of 7 days), or not compliant (defined as >3 days without offloading out of 7 days).
Wear time (days) [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
Wear time will be determined from the Subject Dressing Log at each visit by collecting:
Date of dressing application/change
Reason for change application/change
Lot/batch
Size
Quantity
Debridement performed [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The following debridement details will be recorded for each Subject at each visit:
Debridement performed (No/Yes)
Debridement method
Ease of debridement (Very easy/Easy/Difficult/Very Difficult)
Cleansing performed [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
The following cleansing details will be recorded for each Subject at each visit:
Cleansing performed (No/Yes)
Type of cleansing agent used
Evaluation of all reported adverse events and device deficiencies [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]
If any reported adverse events or device deficiencies are reported, an evaluation will take place to determine root cause.
Source: View full study details on ClinicalTrials.gov
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