Wound Healing and Scar Quality Following Mohs Surgery and Excisional Dermatologic SurgeryNCT03931746
Porcine Xenograft Versus Second Intention Healing
A study testing Porcine xenograft in people with Wound Healing and Scar Quality Following Mohs Surgery and Excisional Dermatologic Surgery, run by Northwell Health at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing and Scar Quality Following Mohs Surgery and Excisional Dermatologic Surgery
- What is being tested?
- Porcine xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jun 2019to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Able to give informed consent themselves
- Willing to return for follow-up visits
- Post-operative defects greater than 8 mm (in greatest diameter or length of circular or oval geometric shape) on the lower extremities (including the feet)
- Single defect
Who cannot join
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Unwilling to return for follow-up
- Pregnant women
Show all 9Show fewer
- Wounds less than 8 mm in length
- Wounds on the head, neck or digits
- Patients in which primary linear closure is recommended
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwell Health Physician Partners Division of Dermatology
Bay Shore, New York, 11706
Northwell Health Physician Partners Division of Dermatology
Lake Success, New York, 11042
About this study
Official title: Porcine Xenograft Versus Second Intention Healing: a Randomized, Evaluator-blinded Clinical Trial
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.
Read the detailed description
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.
- Being tested
- Porcine xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porcine xenograftDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Porcine Xenograft placement | Experimental | Porcine xenograft will be placed on the wound. Receives: Device: Porcine xenograft |
| No porcine xenograft | No intervention | The wound will be allowed to heal via second intention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Between 2.70 to 8.75 months
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start11 Jun 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: Company discontinued production of the Porcine Xenograft
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Wound Healing and Scar Quality Following Mohs Surgery and Excisional Dermatologic SurgeryStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Sharon, Northwell Health
- Investigators
- Victoria Sharon, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931746
- Sponsor's protocol ID
- 18-0715
- Status last verified
- Feb 2023
- First submitted
- 26 Apr 2019
- Last updated
- 20 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 1590931Duteille 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.
PubMed 22360953Raimer 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.
PubMed 21971266Chiu 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.
PubMed 16023938Demling 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.
PubMed 10323611Gerding 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.
PubMed 3411648Hansbrough 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.
PubMed 6478287Horch 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.
PubMed 15993304Becker 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.
PubMed 7233629Hosseini 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.
PubMed 17524562Yang 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.
PubMed 27340740Diwan 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.
PubMed 2789782Howe 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.
PubMed 1960262Zitelli 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.
PubMed 6630602Chern 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.
PubMed 19397669
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porcine Xenograft Versus Second Intention Healing: a Randomized, Evaluator-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT03931746
- Acronym / sponsor ID
- 18-0715
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company discontinued production of the Porcine Xenograft
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Posted 20 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Porcine Xenograft placement | Experimental | Device: Porcine xenograftPorcine xenograft will be placed on the wound. |
| No porcine xenograft | No intervention | –The wound will be allowed to heal via second intention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age
- Able to give informed consent themselves
- Willing to return for follow-up visits
- Post-operative defects greater than 8 mm (in greatest diameter or length of circular or oval geometric shape) on the lower extremities (including the feet)
- Single defect
Key exclusion criteria (9 listed)
- Mentally handicapped
- Unable to understand written and oral English
- Incarceration
- Under 18 years of age
- Unwilling to return for follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porcine xenograftThe 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 | Device | Porcine Xenograft placement |
Primary outcome
Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score
Time frame: Between 2.70 to 8.75 months
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).
8 secondary outcomes
POSAS Patient Scale Total Score
Time frame: 3 months
Healing Time
Time frame: Up to 38 weeks
Ratio of Scar Size to Initial Defect Size
Time frame: 3 months
Pain Score at 1 Week Following Surgery
Time frame: 1 week
Number of Weeks With Pain Score Above 1
Time frame: 3 months
Number of Participants With Infection
Time frame: 3 months
Post-operative Bleeding Requiring Physician Intervention
Time frame: 3 months
Pain Score of 6 or Higher at One Week
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1590931Vanstraelen 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.
- Background: PubMed 22360953Duteille 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.
- Background: PubMed 21971266Raimer 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.
- Background: PubMed 16023938Chiu 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.
- Background: PubMed 10323611Demling 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.
- Background: PubMed 3411648Gerding 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.
- Background: PubMed 6478287Hansbrough 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.
- Background: PubMed 15993304Horch 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.
- Background: PubMed 7233629Becker 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.
- Background: PubMed 17524562Hosseini 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.
- Background: PubMed 27340740Yang 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.
- Background: PubMed 2789782Diwan 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Sharon, MD principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Porcine xenograft in people with Wound Healing and Scar Quality Following Mohs Surgery and Excisional Dermatologic Surgery, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score (time frame: Between 2.70 to 8.75 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931746, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.