Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities

NCT04545476 | Completed Results FDA Device

• 1 other identifier: 201414
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to elucidate if a novel biomaterial containing gelatin, manuka honey, and hydroxyapatite enhances secondary intention healing when compared to conventional secondary intention healing for surgical defects after Mohs micrographic surgery on the head and distal lower extremities (below the knee). This novel biomaterial has already been FDA cleared for surgical wounds.

Conditions

Wound Heal

Keywords

Mohs surgery; Manuka honey; Secondary intention wound healing

Outcome Measures

Primary Outcomes (2)

• Time to Complete Wound Re-epithelialization on the Head

  Complete wound re-epithelialization is defined by epidermal regrowth covering entire post-operative defect. Patients will be seen in office 14 days post-operative, then every 14 days thereafter until complete re-epithelialization is achieved. Patients will also submit photos via Vanderbilt HIPAA compliant Box at regular follow-up intervals (post-operative day 7 then every 14 days thereafter until complete re-epithelialization is achieved). Time elapsed from surgery date to complete re-epithelialization will be noted in days. Time will be measured in days. Increased days indicates slower wound healing.

  14 days post-operative until complete re-epithelialization, approximately 5 months

• Time to Complete Wound Re-epithelialization on the Lower Extremities

  Complete wound re-epithelialization is defined by epidermal regrowth covering entire post-operative defect. Patients will be seen in office 14 days post-operative, then every 14 days thereafter until complete re-epithelialization is achieved. Patients will also submit photos via Vanderbilt HIPAA compliant Box at regular follow-up intervals (post-operative day 7 then every 14 days thereafter until complete re-epithelialization is achieved). Time elapsed from surgery date to complete re-epithelialization will be noted in days. Time will be measured in days. Increased days indicates slower wound healing.

  14 days post-operative until complete re-epithelialization, approximately 5 months

Secondary Outcomes (4)

• Patient Self Reported Pain Score

  Baseline to complete wound re-epithelialization, approximately 5 months

• Number of Participants With at Least One Post-Operative Wound Infection

  Baseline to complete re-epithelialization, approximately 5 months

• Number of Participants With at Least One Report of Post-operative Bleeding

  Baseline to complete re-epithelialization, approximately 5 months

• Skin Thickness

  Baseline to complete wound re-epithelialization, approximately 5 months

Study Arms (4)

APIS Biomaterial on the Head

EXPERIMENTAL

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.

Device: Participants in this group will receive the experimental APIS Biomaterial on the Head.

APIS Biomaterial on the Lower Extremities

EXPERIMENTAL

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.

Device: Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities.

Standard Secondary Intention Healing on the Head

ACTIVE COMPARATOR

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.

Other: Standard Secondary Intention Healing on the Head

Standard Secondary Intention Healing on the Lower Extremities

ACTIVE COMPARATOR

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.

Other: Standard Secondary Intention Healing on the Lower Extremities

Interventions

Participants in this group will receive the experimental APIS Biomaterial on the Head. DEVICE

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 Head

Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities. DEVICE

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.

APIS Biomaterial on the Lower Extremities

Standard Secondary Intention Healing on the Head OTHER

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

Standard Secondary Intention Healing on the Lower Extremities OTHER

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

Eligibility Criteria

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

You may qualify if:

• years of age or older
• 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

You may not qualify if:

• Under 18 years of age
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (13)

• 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

• 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.

  PMID: 6400321 BACKGROUND

• 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.

  PMID: 23027216 BACKGROUND

• 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.

  PMID: 26475539 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

• 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.

  PMID: 7551738 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

• 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.

  PMID: 12828694 BACKGROUND

• 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.

  PMID: 9158402 BACKGROUND

• 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.

  PMID: 30343210 BACKGROUND

• 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.

  PMID: 32804895 BACKGROUND

• 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.

  PMID: 16792648 BACKGROUND

• 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.

  PMID: 37647156 DERIVED

Limitations and Caveats

It was difficult to enroll patients during the COVID-19 pandemic as regular follow up visits were required. Of the 21 patients enrolled in the head group, two were lost to follow up. The low infection rate could possibly be attributed to patients with defects on the distal lower extremities receiving prophylactic antibiotics. Photos taken at follow-up visits were not taken in standardized format, so the difference in wound healing may not be as evident photographically as it was clinically.

Results Point of Contact

• Title: Karen Arnaud
• Organization: Vanderbilt University Medical Center

karen.arnaud@vumc.org

615-322-6485

Study Officials

• Anna S Clayton, MD

  Vanderbilt University Medical Center Dermatology

  STUDY DIRECTOR

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Resident Physician

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 11, 2020
• Study Start: October 8, 2020
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: May 12, 2023
• Results First Posted: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)