Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities
NCT ID: NCT04545476
Last Updated: 2023-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2020-10-08
2022-03-08
Brief Summary
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Detailed Description
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Prior studies utilizing biologic dressings have shown patients report better quality of life during the post-operative period related to less pain, decreased dressing changes, and faster healing times. Biologic dressings provide an alternative to surgical autografts and eliminate the risks associated with graft harvesting (e.g. pain, infection, and scarring). For many patients, the cosmetic outcome following healing is important. However, cosmetic outcome with SIH is variable and depends on many factors, namely location (e.g. concavities favorable), skin laxity, and underlying musculature. Exuberant granulation tissue, hypopigmented and telangiectatic scars are the most frequent adverse cosmetic outcomes with SIH.
The novel biomaterial APIS® (SweetBio, Inc. Memphis, TN) is an advanced synthesis of gelatin, manuka honey, and hydroxyapatite bioengineered to protect wounds, manage exudate, and maintain a moist environment. It is FDA cleared (FDA number K1827250) for wound management across 9 indications including surgical wounds. It has been used successfully in a small case series of 8 patients for post-operative Mohs surgical wounds on the head and distal lower extremities. Time to complete re-epithelialization was 6 weeks (42 days), suggesting a reduction in healing time compared to standard SIH times for the leg and head of 127 and 57 days, respectively. Use of this novel biomaterial to enhance SIH is hypothesized to reduce healing times when compared to standard SIH wound care. This provides a useful option to aid SIH in sites like the lower legs, where healing can be prolonged due to intrinsic factors (e.g., cardiovascular disease, peripheral vascular disease, diabetes) or extrinsic factors (e.g., increased risk of surgical site infection following dermatologic surgery at sites below the knee).
Randomized, comparative studies evaluating augmented SIH compared to conventional SIH in dermatologic surgery are limited. This study aims to evaluate whether use of a novel biomaterial enhances SIH, particularly in shortening time to complete re-epithelialization. Patients undergoing Mohs micrographic surgery amenable to SIH on the head and distal lower extremities will be randomized into one of four groups (standard SIH or biomaterial APIS® enhanced SIH on the head or distal lower extremities). Patients will have regularly scheduled follow-up with questionnaires at each visit. The investigators aim to evaluate whether use of this novel biomaterial decreases complete re-epithelialization times, reduces infection rates, and improves cosmetic outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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APIS Biomaterial on the Head
Participants in this group will receive the experimental APIS Biomaterial on the Head. One layer of APIS® will be applied to the post-operative wound covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape. The biomaterial will be reapplied if it is completely absorbed at follow up and the wound depth below the epithelial level.
Participants in this group will receive the experimental APIS Biomaterial on the Head.
One layer of APIS® will be applied to the post-operative wound on the head covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
APIS Biomaterial on the Lower Extremities
Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities. One layer of APIS® will be applied to the post-operative wound covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape. The biomaterial will be reapplied if it is completely absorbed at follow up and the wound depth below the epithelial level.
Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities.
One layer of APIS® will be applied to the post-operative wound on the lower extremities covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
Standard Secondary Intention Healing on the Head
Participants in this group will receive standard secondary intention wound healing post-operative care on the Head. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
Standard Secondary Intention Healing on the Head
Participants in this group will receive standard secondary intention wound healing post-operative care on the Head. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
Standard Secondary Intention Healing on the Lower Extremities
Participants in this group will receive standard secondary intention wound healing post-operative care on the Lower Extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
Standard Secondary Intention Healing on the Lower Extremities
Participants in this group will receive standard secondary intention wound healing post-operative care on the Lower Extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
Interventions
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Participants in this group will receive the experimental APIS Biomaterial on the Head.
One layer of APIS® will be applied to the post-operative wound on the head covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities.
One layer of APIS® will be applied to the post-operative wound on the lower extremities covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
Standard Secondary Intention Healing on the Head
Participants in this group will receive standard secondary intention wound healing post-operative care on the Head. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
Standard Secondary Intention Healing on the Lower Extremities
Participants in this group will receive standard secondary intention wound healing post-operative care on the Lower Extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
Eligibility Criteria
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Inclusion Criteria
* Post-operative wounds following Mohs surgery on the head or distal lower extremities
* Single Mohs post-operative defect
* Post-operative wounds greater than 1cm in width
* Depth of defect at least to subcutaneous tissue
* Patients have the ability to provide their own wound care
* Agreeable to regularly scheduled follow-up visits and transmission of photos via HIPAA compliant Vanderbilt University Medical Center Box
* Patients are able to provide informed consent
Exclusion Criteria
* Unable to provide informed consent
* Unable to understand oral and written English
* Post-operative wounds not appropriate for secondary intention healing
* Sensitivity or allergy to APIS® biomaterial including collagen and its derivatives, porcine-derived materials or honey
* Immunosuppressed and organ transplant patients
* Post-operative wounds superficial to subcutaneous tissue
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Karen Arnaud
Dermatology Resident Physician
Principal Investigators
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Anna S Clayton, MD
Role: STUDY_DIRECTOR
Vanderbilt University Medical Center Dermatology
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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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.
Zitelli JA. Secondary intention healing: an alternative to surgical repair. Clin Dermatol. 1984 Jul-Sep;2(3):92-106. doi: 10.1016/0738-081x(84)90031-2. No abstract available.
Donaldson MR, Coldiron BM. Scars after second intention healing. Facial Plast Surg. 2012 Oct;28(5):497-503. doi: 10.1055/s-0032-1325643. Epub 2012 Oct 1.
Stebbins WG, Gusev J, Higgins HW 2nd, Nelson A, Govindarajulu U, Neel V. Evaluation of patient satisfaction with second intention healing versus primary surgical closure. J Am Acad Dermatol. 2015 Nov;73(5):865-7.e1. doi: 10.1016/j.jaad.2015.07.019. No abstract available.
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.
Eaglstein WH, Iriondo M, Laszlo K. A composite skin substitute (graftskin) for surgical wounds. A clinical experience. Dermatol Surg. 1995 Oct;21(10):839-43. doi: 10.1111/j.1524-4725.1995.tb00709.x.
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.
Mott KJ, Clark DP, Stelljes LS. Regional variation in wound contraction of mohs surgery defects allowed to heal by second intention. Dermatol Surg. 2003 Jul;29(7):712-22. doi: 10.1046/j.1524-4725.2003.29180.x.
Deutsch BD, Becker FF. Secondary healing of Mohs defects of the forehead, temple, and lower eyelid. Arch Otolaryngol Head Neck Surg. 1997 May;123(5):529-34. doi: 10.1001/archotol.1997.01900050085011.
Chetter IC, Oswald AV, McGinnis E, Stubbs N, Arundel C, Buckley H, Bell K, Dumville JC, Cullum NA, Soares MO, Saramago P. Patients with surgical wounds healing by secondary intention: A prospective, cohort study. Int J Nurs Stud. 2019 Jan;89:62-71. doi: 10.1016/j.ijnurstu.2018.09.011. Epub 2018 Sep 18.
McMurray SL, Wallace MM, Stebbins WG, Clayton AS. Use of a Novel Biomaterial to Enhance Secondary Intention Healing. Dermatol Surg. 2021 Jun 1;47(6):843-844. doi: 10.1097/DSS.0000000000002725. No abstract available.
Dixon AJ, Dixon MP, Askew DA, Wilkinson D. Prospective study of wound infections in dermatologic surgery in the absence of prophylactic antibiotics. Dermatol Surg. 2006 Jun;32(6):819-26; discussion 826-7. doi: 10.1111/j.1524-4725.2006.32167.x.
Arnaud K, Wallace MM, Wheless LE, Stebbins WG, Clayton AS. Novel Biomaterial Containing Gelatin, Manuka Honey, and Hydroxyapatite Enhanced Secondary Intention Healing Versus Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities-A Randomized Controlled Trial: Pilot Study. Dermatol Surg. 2023 Dec 1;49(12):1160-1164. doi: 10.1097/DSS.0000000000003924. Epub 2023 Aug 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201414
Identifier Type: -
Identifier Source: org_study_id
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