Wound HealNCT04545476

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

A study testing 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 Lower Extremities. and Standard Secondary Intention Healing on the Head in people with Wound Heal, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wound Heal
What is being tested?: 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 Lower Extremities. and Standard Secondary Intention Healing on the Head
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 8 Oct 2020to 8 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Wound Heal
Being tested: 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 Lower Extremities., Standard Secondary Intention Healing on the Head, Standard Secondary Intention Healing on the Lower Extremities
Keywords: Mohs surgery, Manuka honey, Secondary intention wound healing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.
Standard Secondary Intention Healing on the HeadOther
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 ExtremitiesOther
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.

Study groups in NCT04545476
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Standard Secondary Intention Healing on the Lower Extremities

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Patient Self Reported Pain Score
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.
Measured: Baseline to complete wound re-epithelialization, approximately 5 months
Number of Participants With at Least One Post-Operative Wound Infection
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.
Measured: Baseline to complete re-epithelialization, approximately 5 months
Number of Participants With at Least One Report of Post-operative Bleeding
Patients will report any bleeding (yes/no) via questionnaires at regularly scheduled follow-up appointments.
Measured: Baseline to complete re-epithelialization, approximately 5 months
Skin Thickness
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.
Measured: Baseline to complete wound re-epithelialization, approximately 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 20208 Mar 2022

First posted11 Sep 2020
Study start8 Oct 2020
Primary completion8 Mar 2022
Study completion8 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Wound HealStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04545476
Sponsor's protocol ID: 201414
Status last verified: May 2023
First submitted: 3 Sep 2020
Last updated: 12 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 6630602
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.
PubMed 6400321
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.
PubMed 23027216
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.
PubMed 26475539
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.
PubMed 19397669
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.
PubMed 7551738
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.
PubMed 27340740
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.
PubMed 12828694
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.
PubMed 9158402
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.
PubMed 30343210
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.
PubMed 32804895
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.
PubMed 16792648
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.
PubMed 37647156

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04545476
Acronym / sponsor ID: 201414
Conditions: Wound Heal
Keywords: Mohs surgery, Manuka honey, Secondary intention wound healing
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 8 Oct 2020 (actual)
Primary completion: 8 Mar 2022 (actual)
Study completion: 8 Mar 2022 (actual)
First posted: 11 Sep 2020 (actual)
Results: Posted 12 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
APIS Biomaterial on the Head	Experimental	Device: 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	Experimental	Device: 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.
Standard Secondary Intention Healing on the Head	Active comparator	Other: Standard Secondary Intention Healing on the HeadParticipants 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	Active comparator	Other: Standard Secondary Intention Healing on the Lower ExtremitiesParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	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 on the lower extremities covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.	Device	APIS Biomaterial on the Lower Extremities
Standard Secondary Intention Healing on the HeadParticipants 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 ExtremitiesParticipants 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

Primary outcome

Time to Complete Wound Re-epithelialization on the Head
Time frame: 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
Time frame: 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.

4 secondary outcomes

Patient Self Reported Pain Score
Time frame: Baseline to complete wound re-epithelialization, approximately 5 months
Number of Participants With at Least One Post-Operative Wound Infection
Time frame: Baseline to complete re-epithelialization, approximately 5 months
Number of Participants With at Least One Report of Post-operative Bleeding
Time frame: Baseline to complete re-epithelialization, approximately 5 months
Skin Thickness
Time frame: Baseline to complete wound re-epithelialization, approximately 5 months

Results and safety

Results posted to the registry on 12 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
APIS Biomaterial on the Head (Intervention Group)	11	10
Standard Secondary Intention Healing on the Head (Control Group)	10	9
APIS Biomaterial on the Lower Extremities (Intervention Group)	8	8
Standard Secondary Intention Healing on the Lower Extremities (Control Group)	8	8

Primary outcome: Time to Complete Wound Re-epithelialization on the Head

Time frame: 14 days post-operative until complete re-epithelialization, approximately 5 months. Mean (Standard Deviation). Unit: days

Measure	APIS Biomaterial on Head (Intervention Group) n = 10	Standard Secondary Intention Healing on the Head (Control Group) n = 9
Value	41.6 (14.7)	43 (12.3)

Population analysed: 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.

Primary outcome: Time to Complete Wound Re-epithelialization on the Lower Extremities

Time frame: 14 days post-operative until complete re-epithelialization, approximately 5 months. Mean (Standard Deviation). Unit: days

Measure	APIS Biomaterial on the Lower Extremities n = 8	Standard Secondary Intention Healing on the Lower Extremities n = 8
Value	49.5 (19.1)	52.7 (20.1)

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

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
APIS Biomaterial on the Head	0 of 0	0 of 0
APIS Biomaterial on the Lower Extremities	0 of 0	0 of 0
Standard Secondary Intention Healing on the Head	0 of 0	0 of 0
Standard Secondary Intention Healing on the Lower Extremities	0 of 0	0 of 0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 6630602Zitelli 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.
Background: PubMed 6400321Zitelli 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.
Background: PubMed 23027216Donaldson 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.
Background: PubMed 26475539Stebbins 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.
Background: PubMed 19397669Chern 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.
Background: PubMed 7551738Eaglstein 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.
Background: PubMed 27340740Yang 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.
Background: PubMed 12828694Mott 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.
Background: PubMed 9158402Deutsch 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.
Background: PubMed 30343210Chetter 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.
Background: PubMed 32804895McMurray 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.
Background: PubMed 16792648Dixon 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna S Clayton, MD study director

Vanderbilt University Medical Center Dermatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Complete Wound Re-epithelialization on the Head (time frame: 14 days post-operative until complete re-epithelialization, approximately 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04545476, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.