Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02704104
• Date of registration: 01/03/2016
• Prospective Registration: No
• Primary sponsor: ARCH Therapuetics
• Public title: Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
• Scientific 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
• Date of first enrolment: February 2016
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02704104
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Ireland

Contacts

• Name: Jack Kelly, MD
• Affiliation: Professor of Surgery

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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understanding that consent may be withdrawn at any time without prejudice to future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

- 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.

Exclusion Criteria:

- 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.

- 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Skin Neoplasms

Intervention(s)

Device: AC5 Topical Hemostatic Device

Primary Outcome(s)

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]

Secondary Outcome(s)

Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30 [Time Frame: 7 and 30 Days Post Procedure]

Time to Hemostasis in Seconds Per Square Centimeter Wound Area [Time Frame: At time of application (Day 0)]

Median Time to Hemostasis (Seconds) [Time Frame: At time of application (Day 0)]

Secondary ID(s)

AC5-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02704104