Clinical trial NCT03931746: Porcine Xenograft Versus Second Intention Healing
Official title: Porcine Xenograft Versus Second Intention Healing: a Randomized, Evaluator-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound Healing and Scar Quality Following Mohs Surgery and Excisional Dermatologic Surgery
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score
timeFrame: Between 2.70 to 8.75 months
Secondary outcomes:
measure: POSAS Patient Scale Total Score
timeFrame: 3 months
measure: Healing Time
timeFrame: Up to 38 weeks
measure: Ratio of Scar Size to Initial Defect Size
timeFrame: 3 months
measure: Pain Score at 1 Week Following Surgery
timeFrame: 1 week
measure: Number of Weeks With Pain Score Above 1
timeFrame: 3 months
measure: Number of Participants With Infection
timeFrame: 3 months
measure: Post-operative Bleeding Requiring Physician Intervention
timeFrame: 3 months
measure: Pain Score of 6 or Higher at One Week
timeFrame: 1 week
Other outcomes:
Locations:
city: Bay Shore
country: United States
facility: Northwell Health Physician Partners Division of Dermatology
state: New York
city: Lake Success
country: United States
facility: Northwell Health Physician Partners Division of Dermatology
state: New York
Study officials:
affiliation: Northwell Health
name: Victoria Sharon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.