Study to Determine if Fibrin Affects the Ability of a Wound to Heal

NCT ID: NCT01253135

Last Updated: 2015-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-11-30

Brief Summary

The objective of this study is to evaluate the potential inhibitory effects of HP802-247 Vehicle on wound closure (healing), by comparing mean days to closure of superficial (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.

Conditions

Effect of Test Articles on the Healing of a Wound Artificially Induced by Liquid Nitrogen Spray

Keywords

Fibrin, white petrolatum, wound healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

White Petrolatum

Group Type: PLACEBO_COMPARATOR

White Petrolatum

Intervention Type: OTHER

Topical application

Test article

Vehicle (fibrinogen)

Group Type: OTHER

Fibrin

Intervention Type: BIOLOGICAL

Topical application of fibrinogen spray, followed by thrombin spray

Interventions

Fibrin

Topical application of fibrinogen spray, followed by thrombin spray

Intervention Type: BIOLOGICAL

White Petrolatum

Topical application

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
• Are male or female, ≥ 18 years of age, of any race.
• Are willing to attend all required study visits, and to comply with study procedures.

Exclusion Criteria

• Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosus, discoid lupus, Ehler Danlos disease, icthyosis vulgaris, vasculitis, or bleeding disorders (coagulopathies).
• Have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as Lichen Planus, Psoriasis, or Vitiligo.
• Have Fitzpatrick scale skin type 6 (never sunburns, deeply pigmented).
• Are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars).
• Have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin C deficiency, connective tissue disorders, or any other disease process that impedes wound healing.
• Are taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs.
• Are using topical glycolic acid products, alpha-hydroxy acid products, retinoids, or chemical peel agents in the treatment areas.
• Are using systemic steroids or immunosuppressant agents, or have used these drugs within the past three months.
• The Principal Investigator may declare any subject ineligible for a valid medical reason.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dept of Dermatology, University of Miami

Miami, Florida, United States

Countries

United States

References

Vivas A, Fox JD, Baquerizo Nole KL, Maderal AD, Badiavas E, Cargill DI, Slade HB, Feldman SR, Kirsner RS. Cryo-Induced Thermal Wounds: A Human Acute Wound Model. J Drugs Dermatol. 2015 Jul;14(7):734-8.

Reference Type: DERIVED

PMID: 26151791 (View on PubMed)

Other Identifiers

802-247-09-017

Identifier Type: -

Identifier Source: org_study_id