Trial Outcomes & Findings for A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients. (NCT NCT02210208)

NCT ID: NCT02210208

Last Updated: 2018-01-10

Results Overview

Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2018-01-10

Participant Flow

Participant milestones

Measure	Overall Study Mepitel® Ag treatment on graft covered wounds 25 patients. Mepilex® Transfer Ag treatment on donor site 19 patients
Period A (Graft Site) STARTED	25
Period A (Graft Site) COMPLETED	23
Period A (Graft Site) NOT COMPLETED	2
Period B (Donor Site) STARTED	19
Period B (Donor Site) COMPLETED	12
Period B (Donor Site) NOT COMPLETED	7

Reasons for withdrawal

Measure	Overall Study Mepitel® Ag treatment on graft covered wounds 25 patients. Mepilex® Transfer Ag treatment on donor site 19 patients
Period A (Graft Site) Withdrawal by Subject	1
Period A (Graft Site) Physician decided not to graft at OR	1
Period B (Donor Site) 7 subjects healed at or before Day 14	7

Baseline Characteristics

Participants in Part A=25 and Participants in Part B=19. Every patient in Part A was not eligible for Part B.

Baseline characteristics by cohort

Measure	All Participants n=25 Participants All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a "Donor site" to help the burn wound heal. The "Donor site" was also treated and these patients were included i part B.
Age, Continuous Part A	28.6 years n=25 Participants • Participants in Part A=25 and Participants in Part B=19. Every patient in Part A was not eligible for Part B.
Age, Continuous Part B	26.9 years n=19 Participants • Participants in Part A=25 and Participants in Part B=19. Every patient in Part A was not eligible for Part B.
Sex: Female, Male Part A · Female	6 Participants n=25 Participants • All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a "Donor site" to help the burn wound heal. The "Donor site" was also treated and these patients were included i part B.
Sex: Female, Male Part A · Male	19 Participants n=25 Participants • All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a "Donor site" to help the burn wound heal. The "Donor site" was also treated and these patients were included i part B.
Sex: Female, Male Part B · Female	4 Participants n=19 Participants • All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a "Donor site" to help the burn wound heal. The "Donor site" was also treated and these patients were included i part B.
Sex: Female, Male Part B · Male	15 Participants n=19 Participants • All participants were enrolled into part A where the subjects were treated with Mepitel Ag on a surgical burn wound. Then, eligible subjects from part A, had skin from a "Donor site" to help the burn wound heal. The "Donor site" was also treated and these patients were included i part B.
Region of Enrollment United States	25 participants n=25 Participants

PRIMARY outcome

Timeframe: 14 days

Population: ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.

Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).

Outcome measures

Measure	Part A: Mepitel Ag n=24 Participants Mepitel Ag treatment on burn wounds with skin grafts Mepitel Ag
Part A: Number of Participants With Healing Day 14: Graft take healed ≥95%=Yes	22 Participants
Part A: Number of Participants With Healing Day 7: Graft take healed ≥95%=No	3 Participants
Part A: Number of Participants With Healing Day 7: Graft take healed ≥95%=Yes	21 Participants
Part A: Number of Participants With Healing Day 14: Graft take healed ≥95%=No	2 Participants

PRIMARY outcome

Timeframe: 14 days with 2 visits

Population: ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.

Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).

Outcome measures

Measure	Part A: Mepitel Ag n=18 Participants Mepitel Ag treatment on burn wounds with skin grafts Mepitel Ag
Part B Day 7: Donor site healed ≥95%=No	15 Participants
Part B Day 7: Donor site healed ≥95%=Yes	3 Participants
Part B Day 14: Graft take/Donor site healed ≥95%=No	2 Participants
Part B Day 14: Donor site healed ≥95%=Yes	4 Participants

SECONDARY outcome

Timeframe: 14 days with 2 visits

Population: ITT population

Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit.

Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing.

Outcome measures

Measure	Part A: Mepitel Ag n=24 Participants Mepitel Ag treatment on burn wounds with skin grafts Mepitel Ag
Part A Secondary Outcome. Day 7: Was a product removal performed: Yes	24 Participants
Part A Secondary Outcome. Day 7: Was there any adherence to the graft: No	20 Participants
Part A Secondary Outcome. Day 7: Was there any adherence to the graft: Yes	4 Participants
Part A Secondary Outcome. Day 7: Graft lift off with removal of product: No	22 Participants
Part A Secondary Outcome. Day 7: Graft lift off with removal of product: Yes	2 Participants
Part A Secondary Outcome. Day 14: Was there any adherence to the graft: No	16 Participants
Part A Secondary Outcome. Day 14: Was there any adherence to the graft: Yes	3 Participants

SECONDARY outcome

Timeframe: 14 days with 2 visits

Population: ITT population

Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.

Outcome measures

Measure	Part A: Mepitel Ag n=18 Participants Mepitel Ag treatment on burn wounds with skin grafts Mepitel Ag
Part B Secondary Outcome. Day 7: Was adherence of product assessed: No	2 Participants
Part B Secondary Outcome. Day 7: Was adherence of product assessed: Yes	16 Participants
Part B Secondary Outcome. Day 7: Was removal assessment performed: Yes	3 Participants
Part B Secondary Outcome. Day 7: Did product stick to donor site: No	2 Participants
Part B Secondary Outcome. Day 7: Did product stick to donor site: Yes	1 Participants
Part B Secondary Outcome. Day 14: Was adherence of product assessed: Yes	6 Participants
Part B Secondary Outcome. Day 14: Was removal assessment performed: Yes	6 Participants
Part B Secondary Outcome. Day 14: Did product stick to donor site: No	6 Participants

Adverse Events

Overall Study

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Overall Study n=25 participants at risk Mepitel Ag treatment and Mepilex Transfer Ag
Infections and infestations infection	4.0% 1/25 • Number of events 1 • 14 days
Blood and lymphatic system disorders leukocytosis	4.0% 1/25 • Number of events 1 • 14 days
Blood and lymphatic system disorders hypocalcemia	4.0% 1/25 • Number of events 1 • 14 days
Blood and lymphatic system disorders hypermagnesemia	4.0% 1/25 • Number of events 1 • 14 days
Blood and lymphatic system disorders hyperphosphatemia	4.0% 1/25 • Number of events 1 • 14 days
Blood and lymphatic system disorders hypertension	4.0% 1/25 • Number of events 1 • 14 days
Musculoskeletal and connective tissue disorders muscle spasm	4.0% 1/25 • Number of events 1 • 14 days
Surgical and medical procedures femoral artery IV site infiltrated	4.0% 1/25 • Number of events 1 • 14 days
Blood and lymphatic system disorders high blood pressure	4.0% 1/25 • Number of events 1 • 14 days

Additional Information

Global Clinical Research Director

Mölnlycke Health Care

Phone: +46 31 722 30 00

Email: info@monlycke.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60