UnknownPhase 4

Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery

United States10 participantsStarted 2015-08

Plain-language summary

The main purpose of this study is to see if there is clinical benefit of using Biovance in reduction of the recurrence of keloids when used to revise them. It will also assess the postoperative complications.

Who can participate

Age range

21 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. been diagnosed with a keloid scar
. a keloid scar that is located on the face, neck, arm, trunk, or groin area
. is between the ages of 21 and 80 years old
. competency as an adult, per applicable state law who is willing to provide written informed consent
. the intent and ability to return for all scheduled and required visits and follow recommended standard post surgical treatment for keloid scar excision.

Exclusion criteria

. clinical evidence of infection of the keloid scar
. any malignancy or a neoplasm at the keloid scar site
. any significant comorbid disease that may interfere with wound healing, known active Hepatitis A, B, or C or Acquired Immune Deficiency Syndrome or is known to be infected with HIV, a known collagen disorder or autoimmune disease \[including systemic lupus erythematosis (SLE), rheumatoid arthritis (RA),fibromyalgia, polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome\]
. received chemotherapy, radiotherapy, immunosuppressives or corticosteroids (greater than 10 mg prednisone-equivalent per day) within the past 30 days.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of keloid scar recurrence after revision surgery with placement of Biovance

Timeframe: 1 year post-surgery

Trial details

NCT IDNCT02521402

SponsorGolla Center for Plastic Surgery

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

Contact for this trial

Dinakar Golla, MD

412-963-6677 drgolla@gollaplasticsurgery.com

View on ClinicalTrials.gov More Keloid Scar trials