Neoplasms

Symptoms and General Pathology

All Conditions

Wounds and Injuries

Neoplasm Metastasis

Neoplastic Processes

Dermatologic Agents

All Drugs and Chemicals

Petrolatum

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 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 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.

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.

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 Head.

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.

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

Standard Secondary Intention Healing on the Head

Standard Secondary Intention Healing on the Lower Extremities

Anna S Clayton, MD

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.

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.

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

Novel Biomaterial Containing Gelatin, Manuka Honey, and Hydroxyapatite Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities - A Randomized Clinical Trial

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.

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.

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.

Patients will report any bleeding (yes/no) via questionnaires at regularly scheduled follow-up appointments.

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.

Vanderbilt University Medical Center

Dermatology Resident Physician

Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.

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 Head

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.

APIS Biomaterial on the Lower Extremities

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.

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.

Participants received the experimental APIS biomaterial on the head. One layer of APIS biomaterial 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 Head (Intervention Group)

Participants in this group received 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 (Control Group)

Participants received the experimental APIS biomaterial on the distal lower extremities. One layer of APIS biomaterial 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 (Intervention Group)

Participants in this group received standard secondary intention wound healing post-operative care on the distal 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 (Control Group)

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Sixteen patients with surgical defects on the lower extremities amenable and conducive for SIH were randomized to intervention or control by block randomization. Subjects were randomized in a 1:1 ratio. Twenty-one patients with surgical defects on the head were randomized in the same manner.

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.

Karen Arnaud

APIS Biomaterial on Head (Intervention Group)

Of the 21 randomized in the head group, 11 were randomized to the intervention group and 10 to the control group. One participant from the intervention group, and one participant from the control group were lost to follow up before complete re-epithelialization was achieved.

Time to Complete Wound Re-epithelialization on the Head

Analysis of re-epithelialization of wounds of the lower extremities with standard secondary intention healing versus APIS biomaterial.

Time to Complete Wound Re-epithelialization on the Lower Extremities

Participants received the experimental APIS biomaterial on the lower extremities. One layer of APIS biomaterial 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 received 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.

Patient Self Reported Pain Score

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

Participants in this group received 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

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

Two patients in the intervention group for the head, 2 patients in control group for the head, 1 patient in intervention group for lower extremities and 1 patient in control group for lower extremities failed to complete a final questionnaire on scar assessment.

Spots Global Cancer Trial Database for participants in this group will receive the experimental apis biomaterial on the lower extremities.