Porcine Xenograft Versus Second Intention Healing
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Porcine Xenograft placement Porcine xenograft will be placed on the wound. |
Device: 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 Intervention: No porcine xenograft The wound will be allowed to heal via second intention. |
Outcome Measures
Primary Outcome Measures
- POSAS Observer Scale Total Score [3 months]
The primary outcome will be the total score of the POSAS observer scale, assessed at the 3-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).
Secondary Outcome Measures
- POSAS Patient Scale Total Score [3 months]
Study participants will complete the POSAS patient scale at the 3-month follow-up visit. The POSAS 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).
- Healing time [3 months]
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.
- Ratio of scare size to initial defect size [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.
- Pain score at 1 week following surgery [3 months]
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).
- Number of weeks with pain score above 1 [3 months]
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).
- Infection [3 months]
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.
- Bleeding [3 months]
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.
- Pain at one week [3 months]
The proportion of patients with a pain score > 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Over 18 years of age
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Able to give informed consent themselves
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Willing to return for follow-up visits
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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)
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Single defect
Exclusion Criteria:
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Mentally handicapped
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Unable to understand written and oral English
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Incarceration
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Under 18 years of age
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Unwilling to return for follow-up
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Pregnant women
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Wounds less than 8 mm in length
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Wounds on the head, neck or digits
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Patients in which primary linear closure is recommended
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwell Health Physician Partners Division of Dermatology | Bay Shore | New York | United States | 11706 |
| 2 | Northwell Health Physician Partners Division of Dermatology | Lake Success | New York | United States | 11042 |
Sponsors and Collaborators
- Northwell Health
Investigators
- Principal Investigator: Victoria Sharon, MD, Northwell Health
Study Documents (Full-Text)
None provided.More Information
Publications
- Becker D. [Temporary dressing of burn wounds using sterile frozen porcine skin (author's transl)]. Unfallheilkunde. 1981 Apr;84(4):158-60. German.
- 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. Review.
- Chiu T, Burd A. "Xenograft" dressing in the treatment of burns. Clin Dermatol. 2005 Jul-Aug;23(4):419-23. Review.
- 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.
- 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.
- Duteille F, Perrot P. Management of 2nd-degree facial burns using the Versajet(®) 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.
- 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.
- 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.
- 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. Epub 2005 Mar 21.
- Hosseini SN, Mousavinasab SN, Fallahnezhat M. Xenoderm dressing in the treatment of second degree burns. Burns. 2007 Sep;33(6):776-81. Epub 2007 May 23.
- 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.
- 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.
- 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.
- 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.
- Zitelli JA. Wound healing by secondary intention. A cosmetic appraisal. J Am Acad Dermatol. 1983 Sep;9(3):407-15.
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