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Project RAPID: Restorative Autologous Platelet biotherapies for Injuries & Delayed wound healing

Randomised controlled trial of platelet rich plasma biotherapies in the management of adult patients with recalcitrant and slow healing wounds following major trauma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84928077
Enrollment
100
Registered
2013-10-31
Start date
2013-10-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Advanced and complex wound care Injury, Occupational Diseases, Poisoning

Interventions

Randomisation of treatment will be computer generated to avoid bias. There are three treatment arms: 1. Standard Advanced Wound Care 2. Autologel autologous Platelet-Rich Plasma Gel plus Bovine throm

Sponsors

Biotherapy Services (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults (male and female patients) over 18 years of age 2. Patients with slow healing wounds and patients with wounds that have not healed within 28 days of the initial injury.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they: 1. Do not consent to participation 2. Refuse to donate blood for the PRP gel treatment 3. If any blood abnormality is detected on testing prior to treatment.

Design outcomes

Primary

MeasureTime frame
Time to 90% wound closure as measured by 3D photography. The wounds will be monitored on a weekly basis.

Secondary

MeasureTime frame
1. Quality of life using the SF-36 health survey (this is the key secondary outcome) 2. Number of treatment 'deferrals' (i.e., temporary rejections) of donors due to low haemoglobin and other factors 3. Markers of platelet concentration, leucocyte levels within the PRP Biotherapies 4. Cognitive ability (reasoning, attention and memory) 5. Levels of physical activity 6. Cost effectiveness 7. Donor attitudes, beliefs and values The wounds will be monitored on a weekly basis using 3D photographic measurement. Secondary outcomes regarding wound infection and antibiotic usage will be monitored on a monthly basis.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026