Porcine Xenograft Versus Second Intention Healing

NCT03931746 | Terminated Results FDA Device

• 1 other identifier: 18-0715
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Wound Healing and Scar Quality Following Mohs Surgery and Excisional Dermatologic Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• POSAS Patient Scale Total Score

  3 months

• Healing Time

  Up to 38 weeks

• Ratio of Scar Size to Initial Defect Size

  3 months

• Pain Score at 1 Week Following Surgery

  1 week

• Number of Weeks With Pain Score Above 1

  3 months

Study Arms (2)

Porcine Xenograft placement

EXPERIMENTAL

Porcine xenograft will be placed on the wound.

Device: Porcine xenograft

No porcine xenograft

NO INTERVENTION

The wound will be allowed to heal via second intention.

Interventions

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

Porcine Xenograft placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Mentally handicapped
• Unable to understand written and oral English
• Incarceration
• Under 18 years of age
• Unwilling to return for follow-up
• Pregnant women
• Wounds less than 8 mm in length
• Wounds on the head, neck or digits
• Patients in which primary linear closure is recommended

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

Northwell Health Physician Partners Division of Dermatology

Bay Shore, New York, 11706, United States

Location

Northwell Health Physician Partners Division of Dermatology

Lake Success, New York, 11042, United States

Location

Related Publications (15)

• 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.

  PMID: 1590931 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.

  PMID: 22360953 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.

  PMID: 21971266 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.

  PMID: 16023938 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.

  PMID: 10323611 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.

  PMID: 3411648 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.

  PMID: 6478287 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.

  PMID: 15993304 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.

  PMID: 7233629 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.

  PMID: 17524562 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.

  PMID: 27340740 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.

  PMID: 2789782 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.

  PMID: 1960262 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.

  PMID: 6630602 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.

  PMID: 19397669 BACKGROUND

Limitations and Caveats

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.

Results Point of Contact

• Title: Sr. Clinical Data Analyst
• Organization: Northwell Health Department of Dermatology

astrunk1@northwell.edu

516-321-8508

Study Officials

• Victoria Sharon, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - Dermatologic Surgery & Dermato-Oncoly, Department of Dermatology, North Shore University Hospital

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: June 11, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 20, 2023
• Results First Posted: March 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)