Trial Outcomes & Findings for Porcine Xenograft Versus Second Intention Healing (NCT NCT03931746)

Last Updated: 2023-03-20

Results Overview

The primary outcome will be the total score of the POSAS observer scale, assessed at the 3-month (+/- 1 month) follow-up visit by two blinded evaluators who will not be involved in the placement of the porcine xenograft. For each patient, scores from the two blinded investigators will be combined by calculating the mean. The POSAS (Patient and Observer Scar Assessment Scale) is a validated assessment tool used for the assessment of all types of scars by professionals and patients. The observer scale is comprised of 6 items (vascularity, pigmentation, thickness, relief, pliability, and surface area) scored on a scale from 1("like normal skin") to 10 ("worst scar imaginable"). The total score is calculated as the sum of the six items (range, 6-60).

Recruitment status

TERMINATED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

Between 2.70 to 8.75 months

Results posted on

2023-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Porcine Xenograft Placement Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft The wound will be allowed to heal via second intention.
Overall Study STARTED	8	6
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Porcine Xenograft Versus Second Intention Healing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Porcine Xenograft Placement n=8 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=6 Participants The wound will be allowed to heal via second intention.	Total n=14 Participants Total of all reporting groups
Age, Continuous	75 years n=5 Participants	80 years n=7 Participants	78 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Surgical Site Shin	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Surgical Site Calf	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Surgical Site Ankle	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Surgical Site Foot	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Initial post-op defect size, area (length x width)	5.7 centimeters squared n=5 Participants	6.0 centimeters squared n=7 Participants	5.7 centimeters squared n=5 Participants
Procedure type Mohs	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Procedure type Excision	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Medication history: blood thinners	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Medication history: immunosuppressants	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Medication history: antibiotics	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Medical history: Diabetes	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Medical history: current tobacco use	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Medical history: venous stasis	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Medical history: Skin infection	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Topical or systemic prophylaxis after surgery	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Between 2.70 to 8.75 months

Population: The Modified Intention-to-Treat (mITT) Population consisted of all patients who received the study intervention and completed the 3-month office visit follow-up, during which the primary endpoint was evaluated.

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=7 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=4 Participants The wound will be allowed to heal via second intention.
Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score	17.0 score on a scale Interval 13.0 to 19.3	20.5 score on a scale Interval 20.0 to 20.6

SECONDARY outcome

Timeframe: 3 months

Study participants will complete the POSAS patient scale at the 3-month follow-up visit. The POSAS (Patient and Observer Scar Assessment Scale) patient scale consists of 6 items assessing patients' subjective opinion of scar quality in terms of pain, itching, color, pliability, thickness, and relief. Each item is scored from 1 (normal pigmentation, no itching, etc.) to 10 ("worst imaginable scar or sensation"). The total score of the POSAS patient scale is calculated as the sum of the six items (range, 6-60).

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=7 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=4 Participants The wound will be allowed to heal via second intention.
POSAS Patient Scale Total Score	15.0 score on a scale Interval 13.0 to 17.5	18.0 score on a scale Interval 15.3 to 19.0

SECONDARY outcome

Timeframe: Up to 38 weeks

Healing time will be measured in weeks based on patient's responses to question 1 of the weekly follow-up questionnaire ("Is the wound completely healed (i.e., wound is completely closed with no open areas)?"). For example, a patient who first replies "Yes" to this question on the third weekly follow-up questionnaire will be assigned a healing time of 3 weeks. A more objective measure of healing time would not be feasible given our resources and patient schedule.

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=7 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=4 Participants The wound will be allowed to heal via second intention.
Healing Time	14.0 weeks Interval 9.5 to 24.0	13.0 weeks Interval 9.25 to 20.25

SECONDARY outcome

Timeframe: 3 months

The initial postoperative defect size will be measured by the investigator prior to intervention in terms of length and width using a sterile ruler. Initial defect area will be calculated as length times width. Scar size will be measured in terms of length and width at the 3-month follow-up visit, and scar area will be calculated as length times width. The outcome will be calculated by dividing the scar area by the initial defect area.

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=7 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=4 Participants The wound will be allowed to heal via second intention.
Ratio of Scar Size to Initial Defect Size	0.43 ratio Interval 0.31 to 0.54	0.35 ratio Interval 0.21 to 0.51

SECONDARY outcome

Timeframe: 1 week

Patients' pain scores will be measured based on their response to question 2 of the weekly follow-up questionnaire. Patients will be asked to rate their current pain level at the operative site on a scale from 1 (no pain) to 10 (worst imaginable pain).

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=7 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=4 Participants The wound will be allowed to heal via second intention.
Pain Score at 1 Week Following Surgery	1.0 score on a scale Interval 1.0 to 5.0	1.5 score on a scale Interval 1.0 to 3.3

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=7 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=4 Participants The wound will be allowed to heal via second intention.
Number of Weeks With Pain Score Above 1	2.0 weeks Interval 0.5 to 2.0	1.0 weeks Interval 0.75 to 1.25

SECONDARY outcome

Timeframe: 3 months

Population: The analysis population for this endpoint was the Safety Population, which consisted of all patients who receive the randomized study intervention.

Patient's charts will be reviewed at the completion of their 3-month office visit follow-up in order to analyze if they visited the dermatologist between the date of surgery and 3-month office visit and if infection was diagnosed.

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=8 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=6 Participants The wound will be allowed to heal via second intention.
Number of Participants With Infection	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 months

Population: The analysis population for this outcome was the Safety Population, consisting of all patients who received the randomized study intervention.

During each of the weekly follow-up questionnaires and during the 3-month follow-up visit, patients will be asked if they have experienced any post-operative bleeding that led to a visit to the physician (yes/no) and if there was any intervention performed by the physician to stop the bleeding (yes/no). The number and percentage of patients who experienced bleeding at any time during the 3-month follow-up period will be reported.

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=8 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=6 Participants The wound will be allowed to heal via second intention.
Post-operative Bleeding Requiring Physician Intervention	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 week

Population: The analysis population for this endpoint was all subjects in the Safety Population with a non-missing pain score at week 1. The safety Population consisted of all patients who received the randomized study intervention.

The proportion of patients with a pain score greater than or equal to 6 at the operative site will be assessed at one week following surgery. This will be based on the patient's response to the weekly follow-up questionnaire, with scores ranging from 1 (no pain) to 10 (worst imaginable pain).

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=8 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=5 Participants The wound will be allowed to heal via second intention.
Pain Score of 6 or Higher at One Week	1 Participants	1 Participants

POST_HOC outcome

Timeframe: 3 months

This outcome describes the number of patients in each treatment group receiving treatment with silver nitrate sticks as a "rescue medication" due to lack of complete wound healing at the 3-month (+- 1 month) visit following surgery.

Outcome measures

Outcome measures
Measure	Porcine Xenograft Placement n=7 Participants Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=4 Participants The wound will be allowed to heal via second intention.
Number of Patients Receiving Rescue Medication	2 Participants	1 Participants

Adverse Events

Porcine Xenograft Placement

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

No Porcine Xenograft

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Porcine Xenograft Placement n=8 participants at risk Porcine xenograft will be placed on the wound. Porcine xenograft: The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft	No Porcine Xenograft n=6 participants at risk The wound will be allowed to heal via second intention.
Infections and infestations Infection	25.0% 2/8 • Number of events 2 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.	33.3% 2/6 • Number of events 2 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.
Injury, poisoning and procedural complications Post-operative Bleeding requiring intervention	0.00% 0/8 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.	16.7% 1/6 • Number of events 1 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.
Injury, poisoning and procedural complications Lymphedema drainage from wound	12.5% 1/8 • Number of events 1 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.	0.00% 0/6 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.
Injury, poisoning and procedural complications Post-operative swelling, tenderness	12.5% 1/8 • Number of events 1 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.	0.00% 0/6 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.
Skin and subcutaneous tissue disorders Stasis dermatitis flare	12.5% 1/8 • Number of events 1 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.	0.00% 0/6 • Adverse event data was collected from the time of the surgery until the patient's wound had completed healed as confirmed at a final follow-up visit. This timeframe ranged from approximately 3 months to 9 months. Adverse event data was collected during weekly phone interview with patients during the first 12 weeks of the study period. Adverse event data was also collected at the planned 3-month follow-up office visit and at subsequent office visits for patients who had not healed completely by 3 months.

Additional Information

Sr. Clinical Data Analyst

Northwell Health Department of Dermatology

Phone: 516-321-8508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place