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

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Other: Standard Secondary Intention Healing on the Head; Other: Standard Secondary Intention Healing on the Lower Extremities; Device: Participants in this group will receive the experimental APIS Biomaterial on the Head.; Device: Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities.

• Registration Number: NCT04545476
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Secondary intention healing (SIH) is often underutilized and has several advantages compared to primary surgical repair. Wound care is minimal, bleeding and infection are rare, and risks associated with primary closure (e.g. hematoma, suture granuloma, graft or flap failure) are non-existent. Importantly, SIH facilitates surveillance of tumor recurrence, whereas flaps and grafts may bury residual tumor. When used in appropriate anatomical locations, SIH leads to high patient satisfaction. However, SIH requires regular wound care that can be cumbersome to patients.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-11
• Study Start: 2020-10-08
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08
• Results First Submitted: 2023-02-08
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Results First Posted: 2023-05-12
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• 18 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Secondary Intention Healing on the Head	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	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.
APIS Biomaterial on the Head	Participants in this group will receive the experimental 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.
APIS Biomaterial on the Lower Extremities	Participants in this group will receive the experimental 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.

Primary Outcome Measures

Name	Time	Method
Time to Complete Wound Re-epithelialization on the Head	14 days post-operative until complete re-epithelialization, approximately 5 months	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.
Time to Complete Wound Re-epithelialization on the Lower Extremities	14 days post-operative until complete re-epithelialization, approximately 5 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Report of Post-operative Bleeding	Baseline to complete re-epithelialization, approximately 5 months	Patients will report any bleeding (yes/no) via questionnaires at regularly scheduled follow-up appointments.
Skin Thickness	Baseline to complete wound re-epithelialization, approximately 5 months	Participants were given a questionnaire at the final visit when complete wound re-epithelialization had been achieved (which was approximately 5 months for each participant) and asked, "Is the thickness of the scar different from your normal skin at present?" Participants reported on a scale of 1 (no, as normal skin) to 10 (yes, very different). These skin thickness scores were then averaged amongst the participants included in each arm.
Patient Self Reported Pain Score	Baseline to complete wound re-epithelialization, approximately 5 months	Patients self-reported their surgical site/wound pain during each 2-week follow-up visit via a questionnaire. Scores were collected from participants until complete wound re-epithelialization, which was approximately 5 months for each participant.; Pain scale will range from 1 (no pain) to 10 (worst pain imaginable). These pain scores were then averaged amongst the participants included in each arm.
Number of Participants With at Least One Post-Operative Wound Infection	Baseline to complete re-epithelialization, approximately 5 months	Post-operative wounds will be assessed for infection at regularly scheduled follow-ups. Any clinically suspected infection (e.g. erythema, purulence, malodor) will be reported.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States