Trial Outcomes & Findings for Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities (NCT NCT04545476)
NCT ID: NCT04545476
Last Updated: 2023-05-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
14 days post-operative until complete re-epithelialization, approximately 5 months
Results posted on
2023-05-12
Participant Flow
Participants were enrolled from 10/8/2020-1/27/2022 at Vanderbilt University Medical Center within the Department of Dermatology Mohs Surgical Unit.
Thirty-seven participants were enrolled in total: 16 to the lower extremity group and 21 to the head group.
Participant milestones
| Measure |
APIS Biomaterial on the Head (Intervention Group)
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.
|
Standard Secondary Intention Healing on the Head (Control 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.
|
APIS Biomaterial on the Lower Extremities (Intervention Group)
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.
|
Standard Secondary Intention Healing on the Lower Extremities (Control 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
8
|
8
|
|
Overall Study
COMPLETED
|
10
|
9
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
APIS Biomaterial on the Head (Intervention Group)
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.
|
Standard Secondary Intention Healing on the Head (Control 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.
|
APIS Biomaterial on the Lower Extremities (Intervention Group)
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.
|
Standard Secondary Intention Healing on the Lower Extremities (Control 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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
APIS Biomaterial on the Head (Intervention Group)
n=11 Participants
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.
|
Standard Secondary Intention Healing on the Head (Control Group)
n=10 Participants
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.
|
APIS Biomaterial on the Lower Extremities (Intervention Group)
n=8 Participants
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.
|
Standard Secondary Intention Healing on the Lower Extremities (Control Group)
n=8 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.5 years
n=11 Participants
|
74.6 years
n=10 Participants
|
67.7 years
n=8 Participants
|
71.2 years
n=8 Participants
|
70.6 years
n=37 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
23 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
37 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 14 days post-operative until complete re-epithelialization, approximately 5 monthsPopulation: 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.
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.
Outcome measures
| Measure |
APIS Biomaterial on Head (Intervention Group)
n=10 Participants
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.
|
Standard Secondary Intention Healing on the Head (Control Group)
n=9 Participants
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.
|
APIS Biomaterial on the Lower Extremities (Intervention Group)
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.
|
Standard Secondary Intention Healing on the Lower Extremities (Control Group)
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.
|
|---|---|---|---|---|
|
Time to Complete Wound Re-epithelialization on the Head
|
41.6 days
Standard Deviation 14.7
|
43 days
Standard Deviation 12.3
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days post-operative until complete re-epithelialization, approximately 5 monthsPopulation: Analysis of re-epithelialization of wounds of the lower extremities with standard secondary intention healing versus APIS biomaterial.
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.
Outcome measures
| Measure |
APIS Biomaterial on Head (Intervention Group)
n=8 Participants
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.
|
Standard Secondary Intention Healing on the Head (Control Group)
n=8 Participants
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.
|
APIS Biomaterial on the Lower Extremities (Intervention Group)
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.
|
Standard Secondary Intention Healing on the Lower Extremities (Control Group)
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.
|
|---|---|---|---|---|
|
Time to Complete Wound Re-epithelialization on the Lower Extremities
|
49.5 days
Standard Deviation 19.1
|
52.7 days
Standard Deviation 20.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to complete wound re-epithelialization, approximately 5 monthsPatients 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.
Outcome measures
| Measure |
APIS Biomaterial on Head (Intervention Group)
n=10 Participants
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.
|
Standard Secondary Intention Healing on the Head (Control Group)
n=9 Participants
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.
|
APIS Biomaterial on the Lower Extremities (Intervention Group)
n=8 Participants
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.
|
Standard Secondary Intention Healing on the Lower Extremities (Control Group)
n=8 Participants
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
|
1.25 score on a scale
Standard Deviation 0.46
|
2.62 score on a scale
Standard Deviation 1.41
|
1.14 score on a scale
Standard Deviation 0.38
|
1.29 score on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Baseline to complete re-epithelialization, approximately 5 monthsPost-operative wounds will be assessed for infection at regularly scheduled follow-ups. Any clinically suspected infection (e.g. erythema, purulence, malodor) will be reported.
Outcome measures
| Measure |
APIS Biomaterial on Head (Intervention Group)
n=10 Participants
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.
|
Standard Secondary Intention Healing on the Head (Control Group)
n=9 Participants
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.
|
APIS Biomaterial on the Lower Extremities (Intervention Group)
n=8 Participants
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.
|
Standard Secondary Intention Healing on the Lower Extremities (Control Group)
n=8 Participants
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 Post-Operative Wound Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to complete re-epithelialization, approximately 5 monthsPatients will report any bleeding (yes/no) via questionnaires at regularly scheduled follow-up appointments.
Outcome measures
| Measure |
APIS Biomaterial on Head (Intervention Group)
n=10 Participants
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.
|
Standard Secondary Intention Healing on the Head (Control Group)
n=9 Participants
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.
|
APIS Biomaterial on the Lower Extremities (Intervention Group)
n=8 Participants
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.
|
Standard Secondary Intention Healing on the Lower Extremities (Control Group)
n=8 Participants
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
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to complete wound re-epithelialization, approximately 5 monthsPopulation: 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.
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.
Outcome measures
| Measure |
APIS Biomaterial on Head (Intervention Group)
n=8 Participants
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.
|
Standard Secondary Intention Healing on the Head (Control Group)
n=7 Participants
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.
|
APIS Biomaterial on the Lower Extremities (Intervention Group)
n=7 Participants
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.
|
Standard Secondary Intention Healing on the Lower Extremities (Control Group)
n=7 Participants
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.
|
|---|---|---|---|---|
|
Skin Thickness
|
2.38 score on a scale
Standard Deviation 0.74
|
6.5 score on a scale
Standard Deviation 1.77
|
4.43 score on a scale
Standard Deviation 1.81
|
3.29 score on a scale
Standard Deviation 1.60
|
Adverse Events
APIS Biomaterial on the Head
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
APIS Biomaterial on the Lower Extremities
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Secondary Intention Healing on the Head
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Secondary Intention Healing on the Lower Extremities
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place