- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07606482
Comparative Study of Fishtail Versus Waisted Teardrop Closure Techniques in Mastectomy Patients
May 18, 2026 updated by: Mehjabeen, University of Faisalabad
Investigators aimed to assess the comparative impact of two different closure techniques on cosmetic outcomes and patient satisfaction; investigators want to analysis operative time, wound healing and postoperative complications in both techniques
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab Province
-
Faisalabad, Punjab Province, Pakistan, 38000
- University of Faisalabad
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
.Inclusion Criteria:
- female patients aged 18 years or older sehdule for mastectomy
- a body mass index (BMI) between 18.5 and 35 kg/m²
- willing and able to provide informed consent.
Exclusion Criteria:
- patients with BMI <18.5 or >35 kg/m²
- those with inflammatory breast cancer,
- prior breast surgery on the same side,
- comorbidities significantly affecting wound healing, such as uncontrolled diabetes
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: fishtail closure technique
In the Fishtail closure group, after standard mastectomy, the lateral flap was shaped into a fish-tail pattern and closed with interrupted sutures, ensuring an even tension distribution along the incision
|
In the Fishtail closure group, after standard mastectomy, the lateral flap was shaped into a fish-tail pattern and closed with interrupted sutures, ensuring an even tension distribution along the incision
|
|
Active Comparator: waisted tear drop
|
In the Waisted Teardrop closure group, the lateral incision was designed in a teardrop shape with a narrowed waist, and closure was performed in layers to balance tension and reduce lateral dog-ear formation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cosmetic outcomes
Time Frame: 1 YEAR
|
To assesc osmetic outcome in terms of correction of dog-ear deformity (Yes/No)
|
1 YEAR
|
|
patient satisfaction
Time Frame: 1 year
|
to assess patient satisfaction five-point Likert scale was used
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operative time
Time Frame: 1 YEAR
|
Analysis of operative time in minutes
|
1 YEAR
|
|
wound healing
Time Frame: 1 year
|
wound healing time was measured in days
|
1 year
|
|
post operative complications
Time Frame: 1 year
|
seroma formation, wound dehiscence, flap necrosis, wound infections (frequency)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Lim GH, Tan HF. Surgical techniques to avoid lateral dog ear of the mastectomy scar: A systematic review. Int J Surg. 2016 Feb;26:73-8. doi: 10.1016/j.ijsu.2015.12.068. Epub 2016 Jan 15.
- Thomas R, Mouat C, King B. Mastectomy flap design: the 'waisted teardrop' and a method to reduce the lateral fold. ANZ J Surg. 2012 May;82(5):329-33. doi: 10.1111/j.1445-2197.2012.06046.x.
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 (Actual)
December 1, 2024
Primary Completion (Actual)
November 30, 2025
Study Completion (Actual)
November 30, 2025
Study Registration Dates
First Submitted
April 30, 2026
First Submitted That Met QC Criteria
May 18, 2026
First Posted (Actual)
May 26, 2026
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- TUF/IRB/464/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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