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

Primary Purpose

Keloid Scar

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Biovance

About this trial

This is an interventional treatment trial for Keloid Scar

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The subject has:

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:

The subject has:

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.
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
condition(s) that would adversely affect subject safety by following the protocol
any contraindication for use of Biovance

Sites / Locations

Golla Center for Plastic Surgery

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Keloid Revision Surgery with Biovance

Arm Description

All enrolled patients will have Biovance applied during Keloid Revision Surgery

Outcomes

Primary Outcome Measures

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

Published data in the literature reporting on keloid scar incidence and recurrence without the use of Biovance may serve as a reference/historical control.

Secondary Outcome Measures

Clinical outcomes of keloid scar revision surgery, including scar size and appearance

Incidence of complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis following revision surgery

Full Information

NCT ID

NCT02521402

First Posted

August 10, 2015

Last Updated

August 11, 2015

Sponsor

Golla Center for Plastic Surgery

1. Study Identification

Unique Protocol Identification Number

NCT02521402

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Golla Center for Plastic Surgery

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keloid Scar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Keloid Revision Surgery with Biovance

Arm Type

Other

Arm Description

All enrolled patients will have Biovance applied during Keloid Revision Surgery

Intervention Type

Biological

Intervention Name(s)

Biovance

Intervention Description

decellularized, dehydrated human amniotic membrane

Primary Outcome Measure Information:

Title

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

Description

Published data in the literature reporting on keloid scar incidence and recurrence without the use of Biovance may serve as a reference/historical control.

Time Frame

1 year post-surgery

Secondary Outcome Measure Information:

Title

Clinical outcomes of keloid scar revision surgery, including scar size and appearance

Time Frame

1 year post-surgery

Title

Incidence of complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis following revision surgery

Time Frame

1 year post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject has: 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: The subject has: 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. 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 condition(s) that would adversely affect subject safety by following the protocol any contraindication for use of Biovance

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dinakar Golla, MD

Phone

412-963-6677

drgolla@gollaplasticsurgery.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dinakar Golla, MD

Organizational Affiliation

Golla Center for Plastic Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Golla Center for Plastic Surgery

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dinakar Golla, MD

Phone

412-963-6677

drgolla@gollaplasticsurgery.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

17644502

Citation

Durani P, Bayat A. Levels of evidence for the treatment of keloid disease. J Plast Reconstr Aesthet Surg. 2008;61(1):4-17. doi: 10.1016/j.bjps.2007.05.007. Epub 2007 Jul 19.

Results Reference

result

PubMed Identifier

20927486

Citation

Gauglitz GG, Korting HC, Pavicic T, Ruzicka T, Jeschke MG. Hypertrophic scarring and keloids: pathomechanisms and current and emerging treatment strategies. Mol Med. 2011 Jan-Feb;17(1-2):113-25. doi: 10.2119/molmed.2009.00153. Epub 2010 Oct 5.

Results Reference

result

PubMed Identifier

24527306

Citation

Viera MH, Vivas AC, Berman B. Update on Keloid Management: Clinical and Basic Science Advances. Adv Wound Care (New Rochelle). 2012 Oct;1(5):200-206. doi: 10.1089/wound.2011.0313.

Results Reference

result

PubMed Identifier

5352921

Citation

Alhady SM, Sivanantharajah K. Keloids in various races. A review of 175 cases. Plast Reconstr Surg. 1969 Dec;44(6):564-6. doi: 10.1097/00006534-196912000-00006. No abstract available.

Results Reference

result

PubMed Identifier

15140214

Citation

Marneros AG, Norris JE, Watanabe S, Reichenberger E, Olsen BR. Genome scans provide evidence for keloid susceptibility loci on chromosomes 2q23 and 7p11. J Invest Dermatol. 2004 May;122(5):1126-32. doi: 10.1111/j.0022-202X.2004.22327.x.

Results Reference

result

PubMed Identifier

15365369

Citation

Lee JY, Yang CC, Chao SC, Wong TW. Histopathological differential diagnosis of keloid and hypertrophic scar. Am J Dermatopathol. 2004 Oct;26(5):379-84. doi: 10.1097/00000372-200410000-00006.

Results Reference

result

PubMed Identifier

26061491

Citation

Smiell JM, Treadwell T, Hahn HD, Hermans MH. Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft. Wounds. 2015 Jun;27(6):158-69.

Results Reference

result

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

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