Measuring the Volumes of Hypertrophic Scars and Keloids,... | NCT06806735

Studies
Measuring the Volumes of Hypertrophic Scars and Keloids, Two Specific Kind of Scars, Over Different Points in Time in Patients Who Have Undergone Surgery and Evaluate 3D-cameras As a Possible Measuring and Documenting Tool Including Volumetry

NCT06806735

Sponsor

University of Zurich

Status

Recruiting

Last Update Posted

Feb 7, 2025Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Keloid Scar Following Surgery
Scars, Hypertrophic
Scar Keloid

Interventions

3D-Pictures

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2025Actual

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Jan 21, 2025

First Submission Date that Met QC Criteria

Feb 3, 2025

First Posted Date

Feb 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2025

Last Update Posted Date

Feb 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Measuring the volumes of hypertrophic scars and keloids, two specific kind of scars, over different points in time in patients who have undergone surgery and evaluate 3D-cameras as a possible measuring and documenting tool including volumetry.

Detailed Description

The objective of this study is to utilize a 3D camera to measure the volumes of hypertrophic scars and keloids in patients at specified time points. The time points for measurement include day 0, as well as 3, 6, and 12 months. The 3D camera will be evaluated for their efficacy in measuring and documenting the volumes of the scars. This evaluation will include volumetry, which is the measurement of the three-dimensional space occupied by an object.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D-Pictures	Other	3D-Pictures will be taken of hypertrophic scars and keloids to document them.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurability	The objective of this study is to determine the feasibility of utilizing 3D cameras to accurately measure hypertrophic scars and keloids. The primary outcome of this study is the measurement of the volumes of hypertrophic scars in cubic millimeters (equivalent to milliliters) over a period of one year. This will allow for an evaluation of the accuracy of 3D photography and for the observation of any potential changes.	Day 0, Month 3, 6 and 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with hypertrophic scars or keloids, written consent to participate in the study, minimum age of 18 years.

Exclusion Criteria:

Absence of written consent, unwillingness to contribute data, inability to understand the study protocol.
lack of hypertrophic scars or keloid

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with hypertrophic scars or keloids of the University Hospital Zurich

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Prof. Dr. med. Soyka	Contact	+41 44 255 58 33		rhinologie@usz.ch

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsspital Zürich	Recruiting	Zurich	Canton of Zurich	8091	Switzerland

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D017439	Cicatrix, Hypertrophic
D007627	Keloid