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Company discontinued production of the Porcine Xenograft
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The purpose of this research study is to test whether it is better to allow patients with post- operative wounds on the legs to heal on their own without a covering or to use a porcine xenograft (skin graft that is made from pig cells) to cover the wound during healing. It is currently not known which option is better in terms of the appearance, complication rate or the impact on the patient's quality of life during the healing process. In this location, it is common receive either treatment.
Porcine xenograft has been used as a barrier to the skin for over 30 years, and due to its wound healing promoting factors, we believe that its use may result in decreased healing time, smaller scar size, better cosmetic outcomes, lower pain levels, and decreased rates of infection and other post-surgical complications.
Upon completion of dermatologic surgery following standard procedures, patients will be randomized into one of two groups (porcine xenograft placement or second intention healing). Weekly follow-up via questionnaires will be conducted as well as a final office visit follow-up at 3 months.
The application of porcine xenograft dressings for wound healing was first studied in 1985, with evidence supporting several benefits when compared to traditional dressings [1]. Subsequent studies have substantiated the use of this dressing for a variety of clinical settings [2,3].
The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking [1,3]. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects [4]. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft [2].
Compared to other biosynthetic dressings, porcine xenografts afford longer wound adherence and can be stored at room temperature [1]. The xenograft triggers rejection by the surgical defect, increasing local vascularization [5]. It also allows for rapid granulation, a reduced risk of infection, as well as reduced wound-related fluid and thermal losses [6-8]. There is also evidence that the quicker wound healing reduces the frequency of dressings, hospitalization time, pain, and analgesic [9,10].
Several clinical case series have extended the use of porcine xenografts to Mohs Micrographic Surgery (MMS) to facilitate post-operative wound care. Porcine xenograft dressings were determined to be safe, well-tolerated, and able to be applied to a wide anatomical range [3,12].
In addition to biosynthetic dressings, healing via second intention remains an alternative [13,14]. The extremities of elderly patients are a common location for wound granulation. Drawbacks to second intention healing on the extremities include prolonged healing time and extended wound care for the patient [15].
Chern et. al. completed a review of biological dressings in dermatologic surgery and concluded that there is a limited number of studies focusing on the conclusive benefits of dressings [16]. Although studies have established that EZ-DERM™ was helpful for wound healing following Mohs surgery, there have not been any definitive statistical measures reported in the literature. Additionally, there is a lack of studies assessing the direct comparison to second intention healing.
Our plan is to perform a direct comparison of porcine xenograft placement to second intent healing. Based on the previously studied benefits of the xenograft as a barrier to the skin and one which has wound healing promoting factors, we believe that its use may result in decreased healing time, smaller scar size, better cosmetic outcomes, lower pain levels, and decreased rates of infection and other post-surgical complications.
Our study will allow surgeons to make informed decisions on whether porcine xenograft dressing is superior to that of second intention healing and thus worth considering.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Porcine Xenograft placement | Experimental | Porcine xenograft will be placed on the wound. |
|
| No porcine xenograft | No Intervention | The wound will be allowed to heal via second intention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porcine xenograft | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score | 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). | Between 2.70 to 8.75 months |
| Measure | Description | Time Frame |
|---|---|---|
| POSAS Patient Scale Total Score | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Sharon, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health Physician Partners Division of Dermatology | Bay Shore | New York | 11706 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1590931 | Background | Vanstraelen P. Comparison of calcium sodium alginate (KALTOSTAT) and porcine xenograft (E-Z DERM) in the healing of split-thickness skin graft donor sites. Burns. 1992 Apr;18(2):145-8. doi: 10.1016/0305-4179(92)90014-l. | |
| 22360953 | Background | Duteille F, Perrot P. Management of 2nd-degree facial burns using the Versajet((R)) hydrosurgery system and xenograft: a prospective evaluation of 20 cases. Burns. 2012 Aug;38(5):724-9. doi: 10.1016/j.burns.2011.12.008. Epub 2012 Feb 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | No Porcine Xenograft | The wound will be allowed to heal via second intention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Includes all patients randomized to receive Porcine Xenograft or Second Intention healing.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score | 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). | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Between 2.70 to 8.75 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment |
Limitations include early termination due to discontinuation of the porcine xenograft product by the manufacturer, leading to small number of subjects analyzed. Primary outcome was assessed outside of the pre-planned follow-up window for several patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Data Analyst | Northwell Health Department of Dermatology | 516-321-8508 | astrunk1@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2019 | Nov 17, 2022 | Prot_SAP_000.pdf |
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To compare wound healing and scar quality following the placement of a porcine xenograft compared to second intention healing of leg wounds following Mohs or excisional surgery.
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The evaluator will not have knowledge of or access to the intervention that was performed and represents a provider not involved in the surgical care of the patient.
|
| 3 months |
| Healing Time | 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. | Up to 38 weeks |
| Ratio of Scar Size to Initial Defect Size | 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. | 3 months |
| Pain Score at 1 Week Following Surgery | 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). | 1 week |
| Number of Weeks With Pain Score Above 1 | 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). | 3 months |
| Number of Participants With Infection | 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. | 3 months |
| Post-operative Bleeding Requiring Physician 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. | 3 months |
| Pain Score of 6 or Higher at One Week | 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). | 1 week |
| Northwell Health Physician Partners Division of Dermatology |
| Lake Success |
| New York |
| 11042 |
| United States |
| 21971266 | Background | Raimer DW, Group AR, Petitt MS, Nosrati N, Yamazaki ML, Davis NA, Kelly BC, Gibson BR, Montilla RD, Wagner RF Jr. Porcine xenograft biosynthetic wound dressings for the management of postoperative Mohs wounds. Dermatol Online J. 2011 Sep 15;17(9):1. |
| 16023938 | Background | Chiu T, Burd A. "Xenograft" dressing in the treatment of burns. Clin Dermatol. 2005 Jul-Aug;23(4):419-23. doi: 10.1016/j.clindermatol.2004.07.027. |
| 10323611 | Background | Demling RH, DeSanti L. Management of partial thickness facial burns (comparison of topical antibiotics and bio-engineered skin substitutes). Burns. 1999 May;25(3):256-61. doi: 10.1016/s0305-4179(98)00165-x. |
| 3411648 | Background | Gerding RL, Imbembo AL, Fratianne RB. Biosynthetic skin substitute vs. 1% silver sulfadiazine for treatment of inpatient partial-thickness thermal burns. J Trauma. 1988 Aug;28(8):1265-9. doi: 10.1097/00005373-198808000-00022. |
| 6478287 | Background | Hansbrough JF, Zapata-Sirvent R, Carroll WJ, Dominic WJ, Wang XW, Wakimoto A. Clinical experience with Biobrane biosynthetic dressing in the treatment of partial thickness burns. Burns Incl Therm Inj. 1984 Aug;10(6):415-9. doi: 10.1016/0305-4179(84)90081-0. |
| 15993304 | Background | Horch RE, Jeschke MG, Spilker G, Herndon DN, Kopp J. Treatment of second degree facial burns with allografts--preliminary results. Burns. 2005 Aug;31(5):597-602. doi: 10.1016/j.burns.2005.01.011. Epub 2005 Mar 21. |
| 7233629 | Background | Becker D. [Temporary dressing of burn wounds using sterile frozen porcine skin (author's transl)]. Unfallheilkunde. 1981 Apr;84(4):158-60. No abstract available. German. |
| 17524562 | Background | Hosseini SN, Mousavinasab SN, Fallahnezhat M. Xenoderm dressing in the treatment of second degree burns. Burns. 2007 Sep;33(6):776-81. doi: 10.1016/j.burns.2006.10.396. Epub 2007 May 23. |
| 27340740 | Background | Yang YW, Ochoa SA. Use of Porcine Xenografts in Dermatology Surgery: The Mayo Clinic Experience. Dermatol Surg. 2016 Aug;42(8):985-91. doi: 10.1097/DSS.0000000000000804. |
| 2789782 | Background | Diwan R, Tromovitch TA, Glogau RG, Stegman SJ. Secondary intention healing. The primary approach for management of selected wounds. Arch Otolaryngol Head Neck Surg. 1989 Oct;115(10):1248-9. doi: 10.1001/archotol.1989.01860340102027. |
| 1960262 | Background | Howe NR, Lang PG Jr. Daily observations during healing of a full-thickness human surgical wound by second intention. J Dermatol Surg Oncol. 1991 Dec;17(12):933-5. doi: 10.1111/j.1524-4725.1991.tb01692.x. |
| 6630602 | Background | Zitelli JA. Wound healing by secondary intention. A cosmetic appraisal. J Am Acad Dermatol. 1983 Sep;9(3):407-15. doi: 10.1016/s0190-9622(83)70150-7. |
| 19397669 | Background | Chern PL, Baum CL, Arpey CJ. Biologic dressings: current applications and limitations in dermatologic surgery. Dermatol Surg. 2009 Jun;35(6):891-906. doi: 10.1111/j.1524-4725.2009.01153.x. Epub 2009 Apr 6. |
| BG001 | No Porcine Xenograft | The wound will be allowed to heal via second intention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Surgical Site | Count of Participants | Participants |
|
| Initial post-op defect size, area (length x width) | Median | Inter-Quartile Range | centimeters squared |
|
| Procedure type | Count of Participants | Participants |
|
| Medication history: blood thinners | Count of Participants | Participants |
|
| Medication history: immunosuppressants | Count of Participants | Participants |
|
| Medication history: antibiotics | Count of Participants | Participants |
|
| Medical history: Diabetes | Count of Participants | Participants |
|
| Medical history: current tobacco use | Count of Participants | Participants |
|
| Medical history: venous stasis | Count of Participants | Participants |
|
| Medical history: Skin infection | Count of Participants | Participants |
|
| Topical or systemic prophylaxis after surgery | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | 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 |
| OG001 | No Porcine Xenograft | The wound will be allowed to heal via second intention. |
|
|
|
| Secondary | POSAS Patient Scale Total Score | 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). | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
|
|
|
|
| Secondary | Healing Time | 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. | 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. | Posted | Median | Inter-Quartile Range | weeks | Up to 38 weeks |
|
|
|
|
| Secondary | Ratio of Scar Size to Initial Defect Size | 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. | 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. | Posted | Median | Inter-Quartile Range | ratio | 3 months |
|
|
|
|
| Secondary | Pain Score at 1 Week Following Surgery | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 1 week |
|
|
|
|
| Secondary | Number of Weeks With Pain Score Above 1 | 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). | 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. | Posted | Median | Inter-Quartile Range | weeks | 3 months |
|
|
|
|
| Secondary | Number of Participants With Infection | 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. | The analysis population for this endpoint was the Safety Population, which consisted of all patients who receive the randomized study intervention. | Posted | Count of Participants | Participants | 3 months |
|
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|
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| Secondary | Post-operative Bleeding Requiring Physician 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. | The analysis population for this outcome was the Safety Population, consisting of all patients who received the randomized study intervention. | Posted | Count of Participants | Participants | 3 months |
|
|
|
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| Secondary | Pain Score of 6 or Higher at One Week | 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). | 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. | Posted | Count of Participants | Participants | 1 week |
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| Post-Hoc | Number of Patients Receiving Rescue Medication | 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. | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | No Porcine Xenograft | The wound will be allowed to heal via second intention. | 0 | 6 | 0 | 6 | 3 | 6 |
| Post-operative Bleeding requiring intervention | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lymphedema drainage from wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post-operative swelling, tenderness | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Stasis dermatitis flare | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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