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

August 11, 2015 updated by: Golla Center for Plastic Surgery

Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance, a Dehydrated Decellularized Human Amnion Membrane Allograft, Following Keloid Revision Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To assess the performance of Biovance, patients will consulted regarding the history and previous treatment of their keloid. Once patients are deemed to be appropriate candidates, they will be enrolled in the study. Operatively, the old scar will be completely excised. Then the Biovance will be laid in the base of the wound. After this is performed, extensive undermining will be done to close the wound in layers.

All post-revision complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis) will be assessed and recorded by the investigator. Patients will be reviewed to obtain demographic and risk factor (such as age, body mass index, smoking) data. Data on adjuvant therapy use (previous surgeries, treatments for keloid scar) will be collected. Surgical technique details (such as incision size and closure technique) will also be recorded for each patient. Photographs documenting the pre-, intra- and post-revision clinical course of patients will be collected.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The subject has:

  1. been diagnosed with a keloid scar
  2. a keloid scar that is located on the face, neck, arm, trunk, or groin area
  3. is between the ages of 21 and 80 years old
  4. competency as an adult, per applicable state law who is willing to provide written informed consent
  5. 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:

The subject has:

  1. clinical evidence of infection of the keloid scar
  2. any malignancy or a neoplasm at the keloid scar site
  3. 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]
  4. received chemotherapy, radiotherapy, immunosuppressives or corticosteroids (greater than 10 mg prednisone-equivalent per day) within the past 30 days.
  5. a known history of abuse of alcohol or drugs (prescribed or illegal), significant psychiatric personality or psychotic disorder requiring chronic psychotropic therapy, or gross noncompliance to recommended therapies
  6. condition(s) that would adversely affect subject safety by following the protocol
  7. any contraindication for use of Biovance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Keloid Revision Surgery with Biovance
All enrolled patients will have Biovance applied during Keloid Revision Surgery
Biological: Biovance
decellularized, dehydrated human amniotic membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of keloid scar recurrence after revision surgery with placement of Biovance
Time Frame: 1 year post-surgery
Published data in the literature reporting on keloid scar incidence and recurrence without the use of Biovance may serve as a reference/historical control.
1 year post-surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical outcomes of keloid scar revision surgery, including scar size and appearance
Time Frame: 1 year post-surgery
1 year post-surgery
Incidence of complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis following revision surgery
Time Frame: 1 year post-surgery
1 year post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golla Center for Plastic Surgery

Investigators

  • Principal Investigator: Dinakar Golla, MD, Golla Center for Plastic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Golla-01-Keloid

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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