Comparative Study of Fishtail Versus Waisted Teardrop Closure Techniques in Mastectomy Patients

NCT07606482 | Completed DMC

• 1 other identifier: TUF/IRB/464/24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Closure Technique

Outcome Measures

Primary Outcomes (2)

• cosmetic outcomes

  To assesc osmetic outcome in terms of correction of dog-ear deformity (Yes/No)

  1 YEAR

• patient satisfaction

  to assess patient satisfaction five-point Likert scale was used

  1 year

Secondary Outcomes (3)

• Operative time

  1 YEAR

• wound healing

  1 year

• post operative complications

  1 year

Study Arms (2)

fishtail closure technique

ACTIVE COMPARATOR

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

Procedure: fishtail closure technique

waisted tear drop

ACTIVE COMPARATOR

Procedure: closure technique waisted tear drop

Interventions

fishtail closure technique PROCEDURE

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

fishtail closure technique

closure technique waisted tear drop PROCEDURE

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

waisted tear drop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

University of Faisalabad

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 26776364 BACKGROUND

• 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.

  PMID: 23305050 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 26, 2026
• Study Start: December 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: May 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)