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

NCT02704104 | Completed Results DMC

• 1 other identifier: AC5-1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Neoplasms

Keywords

topical hemostat; self-assembling peptide barrier

Outcome Measures

Primary Outcomes (1)

• 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.

  30 Days Post Procedure

Secondary Outcomes (3)

• Median Time to Hemostasis (Seconds)

  At time of application (Day 0)

• Time to Hemostasis in Seconds Per Square Centimeter Wound Area

  At time of application (Day 0)

• Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30

  7 and 30 Days Post Procedure

Other Outcomes (1)

• Time to Hemostasis in Patients Who Were Taking or Not Taking Anti Platelet Medication

  Day 0

Study Arms (2)

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

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

Device: AC5 Topical Hemostatic Device

Interventions

AC5 Topical Hemostatic Device DEVICE

Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient

AC5 Topical Hemostatic Device; Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arch Therapeutics: lead

Study Sites (1)

University College Hospital

Galway, Ireland

Location

Related Publications (1)

• 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.

  PMID: 2868173 RESULT

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Medical/Scientific Affairs
• Organization: Arch Therapeutics, Inc

jprats@archtherapeutics.com

617 431-2313

Study Officials

• Jack Kelly, MD

  Professor of Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 9, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 7, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-08

Locations

IE (1)