Skin NeoplasmsNCT02704104
Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
A study testing AC5 Topical Hemostatic Device in people with Skin Neoplasms, run by Arch Therapeutics at 1 site in Ireland.
Trial summary
This study is designed to monitor patient safety after excision of skin lesions and subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5 for controlling bleeding in skin wounds. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Neoplasms
- What is being tested?
- AC5 Topical Hemostatic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2016to Jun 2016
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 18 and 85.
- Voluntary written informed consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
- Scheduled for excision of 2 (two) or more skin lesions from their trunk or upper limbs (defined as lying below the level of the inferior border of the patient's mandible).
- If subjects is currently prescribed an antiplatelet therapy, it must from one of the following therapies at levels as per hospital protocol:
- Antiplatelet monotherapy with one of the following agents:
- Aspirin
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- Clopidogrel (thienopyridine-class antiplatelet agent)
- Ticagrelor
- Dipyridamole
- Female subjects must meet at least one of the following additional criteria:
- Surgically sterile with bilateral tubal ligation or hysterectomy.
- Post-menopausal for at least one year.
- If of child-bearing potential, practicing an acceptable method of birth control for the duration of the clinical investigation as judged by the Investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.
- Subjects willing to undergo pre-and post-clinical investigation blood and urine collection, physical exams and laboratory investigations.
Who cannot join
- Active infection as demonstrated by temperature > 37.5 C and clinical features of active infection.
- Wound expected to expose bone or tendon.
- Wound expected to require topical antibiotics.
- Know contraindication or reaction to Tegaderm use.
- Presence of malignancy or clinical expectation of malignancy based on examination.
- Known immunosuppression or taking immunosuppressive agents including systemic steroids.
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- Plan for adjunctive flap or graft procedure to obtain closure of the wound(s) subject to this study.
- History of severe co-morbidity with expected patient survival ≤ 6 months.
- Pregnancy or lactation
- Intake of investigational drugs within 28 days prior to enrollment.
- Currently taking oral anticoagulants
- History of concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
- History of clinically significant, active disease (within 12 months prior to enrollment) of the pulmonary, gastrointestinal, neurological, genitourinary, renal, or haematological system, that in the opinion of the Principal Investigator, may confound the results of the trial or pose additional risk to the subject following the administration of AC5.
- History of clinically significant cardiac disorder, defined as: acute coronary syndrome, congestive heart failure (NYHA class III/IV), diagnosis of unstable angina pectoris, cerebral stroke and or myocardial infarction within the last 12 months or planned coronary or carotid revascularisation procedures anytime through 30 Day follow-up.
- History of severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg).
- Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.
- Presence of significant cognitive impairment (Mini Mental Status Examination <22) or mental incapacity.
- Unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel.
- Known or suspected active abuse of alcohol, narcotics or non-prescription drugs.
- Other planned surgical procedures within 30 days prior to or 30 days post-index procedure.
- Prior enrollment in this AC5 clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Single-Blind Investigation to Evaluate the Safety and Performance of the AC5 Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
This study is designed to monitor patient safety after excision of skin lesions and subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5 for controlling bleeding in skin wounds.
Read the detailed description
This is a randomized, controlled single-blind pilot study to evaluate the safety and performance of AC5 following excision of lesions from the trunk or upper limbs under local anesthetic, in patients currently prescribed or not prescribed antiplatelet monotherapy.
Each patient had sequential shave excision of two lesions (one treatment, one Control) at the same sitting. The sequence of wound treatment (AC5 first or Control first) was randomized.
Study and Control treatments were administered immediately after lesion excision, followed by determination of time to hemostasis (TTH), and application of an occlusive water-resistant dressing
- Conditions
- Skin Neoplasms
- Being tested
- AC5 Topical Hemostatic Device
- Keywords
- topical hemostat, self-assembling peptide barrier
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC5 Topical Hemostatic DeviceDevice
Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient
| Study group | Role | What they receive |
|---|---|---|
| AC5 Topical Hemostatic Device | Experimental | The intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion Receives: Device: AC5 Topical Hemostatic Device |
| Control | Placebo comparator | The intervention in this arm is the application of saline (Control) to a freshly excised skin lesion Receives: Device: AC5 Topical Hemostatic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up
Local reactions to clinical investigation product (pain, edema, rash, cellulitis, localized infectious processes, other) detected during clinical investigation follow up.
Systemic reactions after administration of clinical investigation product (fever, allergic reaction, anaphylaxis or any clinical untoward event) detected during clinical investigation follow up.
Measured: 30 Days Post Procedure
Secondary outcomes (3)
Median Time to Hemostasis (Seconds)
Measure of time from application of treatment or control to the wound, to bleeding cessation
Measured: At time of application (Day 0)
Time to Hemostasis in Seconds Per Square Centimeter Wound Area
Measure of time from application of treatment or control to the wound, to bleeding cessation/ divided by wound area
Measured: At time of application (Day 0)
Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30
The Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay longer than 14 days (ASEPSIS) Wound Score (reference 1) was used to assess wound healing and overall wound sepsis. This multipoint system is reported as a total score ranging from 0 to 30 points in the first 7 days postoperatively. Additional points after 7 days can be added for additional treatments such as use of antibiotics, drainage of pus under local anesthesia, and debridement of the wound; and isolation of bacteria or duration of stay, for a total score of from 0 to 70 points by day 30. Total scores from 0-10 indicate satisfactory healing, from 11 to 20=disturbance of healing, from 21 to 30=minor wound infection, from 31 to 40=moderate wound infection, and >40 points signifies severe infection. For this study, the number of wounds with ASEPSIS score = 0 was counted.
Measured: 7 and 30 Days Post Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionJun 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for Skin NeoplasmsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arch Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack Kelly, MD, Principal investigator, Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704104
- Sponsor's protocol ID
- AC5-1
- Status last verified
- Aug 2018
- First submitted
- 1 Mar 2016
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet. 1986 Feb 8;1(8476):311-3. doi: 10.1016/s0140-6736(86)90838-x.
PubMed 2868173
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Single-Blind Investigation to Evaluate the Safety and Performance of the AC5 Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
- ClinicalTrials.gov ID
- NCT02704104
- Acronym / sponsor ID
- AC5-1
- Conditions
- Skin Neoplasms
- Keywords
- topical hemostat, self-assembling peptide barrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Arch TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 7 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to monitor patient safety after excision of skin lesions and subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5 for controlling bleeding in skin wounds.
Detailed description
This is a randomized, controlled single-blind pilot study to evaluate the safety and performance of AC5 following excision of lesions from the trunk or upper limbs under local anesthetic, in patients currently prescribed or not prescribed antiplatelet monotherapy.
Each patient had sequential shave excision of two lesions (one treatment, one Control) at the same sitting. The sequence of wound treatment (AC5 first or Control first) was randomized.
Study and Control treatments were administered immediately after lesion excision, followed by determination of time to hemostasis (TTH), and application of an occlusive water-resistant dressing
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC5 Topical Hemostatic Device | Experimental | Device: AC5 Topical Hemostatic DeviceThe intervention in this arm is the application of a topical hemostatic agent (AC5) to a freshly excised skin lesion |
| Control | Placebo comparator | Device: AC5 Topical Hemostatic DeviceThe intervention in this arm is the application of saline (Control) to a freshly excised skin lesion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women between the ages of 18 and 85.
- Voluntary written informed consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
- Scheduled for excision of 2 (two) or more skin lesions from their trunk or upper limbs (defined as lying below the level of the inferior border of the patient's mandible).
- If subjects is currently prescribed an antiplatelet therapy, it must from one of the following therapies at levels as per hospital protocol:
- Antiplatelet monotherapy with one of the following agents:
Key exclusion criteria (21 listed)
- Active infection as demonstrated by temperature > 37.5 C and clinical features of active infection.
- Wound expected to expose bone or tendon.
- Wound expected to require topical antibiotics.
- Know contraindication or reaction to Tegaderm use.
- Presence of malignancy or clinical expectation of malignancy based on examination.
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 |
|---|---|---|
| AC5 Topical Hemostatic DeviceRandomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient | Device | AC5 Topical Hemostatic Device, Control |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up
Time frame: 30 Days Post Procedure
Local reactions to clinical investigation product (pain, edema, rash, cellulitis, localized infectious processes, other) detected during clinical investigation follow up. Systemic reactions after administration of clinical investigation product (fever, allergic reaction, anaphylaxis or any clinical untoward event) detected during clinical investigation follow up.
3 secondary outcomes
Median Time to Hemostasis (Seconds)
Time frame: At time of application (Day 0)
Time to Hemostasis in Seconds Per Square Centimeter Wound Area
Time frame: At time of application (Day 0)
Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30
Time frame: 7 and 30 Days Post Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 2868173Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet. 1986 Feb 8;1(8476):311-3. doi: 10.1016/s0140-6736(86)90838-x.
- Individual participant dataSharing planned: Undecided
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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.
Jack Kelly, MD principal investigator
Professor of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AC5 Topical Hemostatic Device in people with Skin Neoplasms, run by Arch Therapeutics at 1 site in Ireland.
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 14 inclusion and 21 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 7 Aug 2018. 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 Ireland. 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. Some participants in this study may receive a placebo. 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 7 Aug 2018). 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?
Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up (time frame: 30 Days Post Procedure). 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 NCT02704104, which also lists 1 linked publication.
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 7 Aug 2018.