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Abdominal Scar Improvement in Microsurgical Breast Reconstruction

Primary Purpose

Cicatrix, Breast Reconstruction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neodyne Device
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cicatrix

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female Subjects who have undergone unilateral/bilateral microsurgical breast reconstruction with free abdominal flaps within approximately 1 week (4-8 days) prior to study participation.
  2. Appearance of subject's incision is aesthetically similar across length of incision
  3. Age >18
  4. Subject has the ability to read and comprehend as required by the protocol and the informed consent.
  5. Subject must be able to provide written informed consent prior to participation in the study.

Exclusion Criteria:

  1. Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
  2. Subjects diagnosed with scleroderma.
  3. Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
  4. Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
  5. Subjects with inability to maintain adequate care of incision.
  6. Subjects with a weight loss of > 100 lbs within 6 months from date of surgery.
  7. Subjects who currently smoke.
  8. Subjects taking steroid therapy (systemic or inhaled) within 2 months from date of study enrollment.
  9. Subject does not qualify for the study in the opinion of the investigators.

Sites / Locations

  • Stanford University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Neodyne Device

Control

Arm Description

After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision (Arm Title: Control) will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing.

See above

Outcomes

Primary Outcome Measures

Scar Assessment
The primary endpoint is the difference between the assessments of the scar appearance for the treated as compared to the control incision sites. Incisions will be evaluated by an objective independent expert panel at six months post surgery. The panel will review close-up photographic records, taken at the 6 month study endpoint, of the control incision site and the treated incision site. The subject will complete the Scar Q questionnaire and both the investigator and the subject will complete the Patient and Observer Scar Assessment Scale (POSAS). It is expected that the scar from the incision area covered by Neodyne Dressing will be minimized when compared to the scar from the untreated incision area.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2022
Last Updated
October 12, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05377723
Brief Title
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
Official Title
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Microsurgical breast reconstruction is most commonly performed with free abdominal flaps, which leave a long transverse lower abdominal scar. Due to tension across the incision, these scars frequently widen and hypertrophy. Hence, modalities that can reduce this tendency, thus, improving scar appearance are desirable. Here, we wish to investigate the impact of the Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is novel in that it is the first RCT investigating the effect of the embrace device on scar appearance in the context of microsurgical breast reconstruction.
Detailed Description
Adult (>18 years) women who have undergone microsurgical breast reconstruction with free abdominal flap(s) approximately 1 week (5-10 days) prior to study participation will be approached by the clinical research team during their first postoperative clinic visit; the protocol asks for the device to be applied at this point. Investigators will only invite those subjects to participate whose incisions, at the 1 week postoperative visit, appear to be uniformly aesthetically similar across the length of the incision. Informed consent for randomization and study participation will be obtained. After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing. At the 8th week visit subjects and investigators will complete an evaluation of the incision/scar. Subjects will return to the Investigator's office at 12 weeks from the date of the procedure for another evaluation of the incision/scar. The primary study endpoint will be evaluated at 6 months from the date of the procedure. Subjects will also be offered the opportunity to provide additional photographic evaluations at 12 months after surgery in conjunction with a standard clinic visit.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neodyne Device
Arm Type
Experimental
Arm Description
After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision (Arm Title: Control) will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing.
Arm Title
Control
Arm Type
Other
Arm Description
See above
Intervention Type
Device
Intervention Name(s)
Neodyne Device
Intervention Description
See Arm Description: Neodyne Device
Primary Outcome Measure Information:
Title
Scar Assessment
Description
The primary endpoint is the difference between the assessments of the scar appearance for the treated as compared to the control incision sites. Incisions will be evaluated by an objective independent expert panel at six months post surgery. The panel will review close-up photographic records, taken at the 6 month study endpoint, of the control incision site and the treated incision site. The subject will complete the Scar Q questionnaire and both the investigator and the subject will complete the Patient and Observer Scar Assessment Scale (POSAS). It is expected that the scar from the incision area covered by Neodyne Dressing will be minimized when compared to the scar from the untreated incision area.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Subjects who have undergone unilateral/bilateral microsurgical breast reconstruction with free abdominal flaps within approximately 1 week (4-8 days) prior to study participation. Appearance of subject's incision is aesthetically similar across length of incision Age >18 Subject has the ability to read and comprehend as required by the protocol and the informed consent. Subject must be able to provide written informed consent prior to participation in the study. Exclusion Criteria: Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus. Subjects diagnosed with scleroderma. Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives. Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application. Subjects with inability to maintain adequate care of incision. Subjects with a weight loss of > 100 lbs within 6 months from date of surgery. Subjects who currently smoke. Subjects taking steroid therapy (systemic or inhaled) within 2 months from date of study enrollment. Subject does not qualify for the study in the opinion of the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Meyer
Phone
650-721-1807
Email
smeyer27@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Momeni, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arash Momeni, MD
Phone
650-723-6189
Email
smeyer27@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Abdominal Scar Improvement in Microsurgical Breast Reconstruction

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