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Platelets for Acute Wound Healing

Platelets in Acute Wounds: A Punch Biopsy Study (PAWS II)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00125086
Enrollment
4
Registered
2005-07-29
Start date
2005-07-31
Completion date
2006-02-28
Last updated
2005-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds

Keywords

wounds, healing, Acute wounds healing by secondary intention

Brief summary

This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment.

Detailed description

Platelets contribute to the healing process in soft tissue by providing the initial hemostasis that occurs following injury, a framework for fibrin matrix formation and contribution of growth factors. According to the US National Institutes of Health, surgical procedures are considered a form of controlled injury, so many of the complications faced by surgery patients are very similar to those faced by trauma patients. Scientists are currently investigating ways to treat wounds caused by trauma, burns or surgical inventions with biological agents (i.e. growth factors) or new drugs. Growth factor priming of acute wound sites pre-activates the cellular and molecular components of tissue repair, prior to tissue injury. Objectives are aimed at gathering information to establish evidence that autologous platelet gel positively effects the healing of acute wounds.

Interventions

Sponsors

Medtronic
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Normal volunteers * 18 years old or older

Exclusion criteria

* Pregnant or lactating * Diabetic, keloid former, collagen vascular disease * Smoker * Body mass index \>30kg/m2 * Known history of HIV/AIDS; Hepatitis A, B, or C * Bleeding disorder * Aspirin, non-steroidal anti-inflammatory drug (NSAID) or anticoagulant user * Cancer, or treatment for cancer, in past 5 years

Design outcomes

Primary

MeasureTime frame
Time to 100% wound closure, measured at Days 7, 14, 21, 28, 35

Secondary

MeasureTime frame
Measurements of wound depth at each visit
Measurement of residual scarring at 6 months post wounding

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026