Closure TechniqueNCT07606482
Comparative Study of Fishtail Versus Waisted Teardrop Closure Techniques in Mastectomy Patients
A study testing fishtail closure technique and closure technique waisted tear drop in people with Closure Technique, run by University of Faisalabad at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Closure Technique
- What is being tested?
- fishtail closure technique and closure technique waisted tear drop
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- fishtail closure technique, closure technique waisted tear drop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fishtail closure techniqueProcedure or surgery
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
closure technique waisted tear dropProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: fishtail closure technique |
| waisted tear drop | Active comparator | Not described Receives: Procedure: closure technique waisted tear drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
cosmetic outcomes
To assesc osmetic outcome in terms of correction of dog-ear deformity (Yes/No)
Measured: 1 YEAR
patient satisfaction
to assess patient satisfaction five-point Likert scale was used
Measured: 1 year
Secondary outcomes (3)
Operative time
Analysis of operative time in minutes
Measured: 1 YEAR
wound healing
wound healing time was measured in days
Measured: 1 year
post operative complications
seroma formation, wound dehiscence, flap necrosis, wound infections (frequency)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Dec 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Closure TechniqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehjabeen, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606482
- Sponsor's protocol ID
- TUF/IRB/464/24
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26776364Thomas 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.
PubMed 23305050
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Fishtail Versus Waisted Teardrop Closure Techniques in Mastectomy Patients
- ClinicalTrials.gov ID
- NCT07606482
- Acronym / sponsor ID
- TUF/IRB/464/24
- Conditions
- Closure Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fishtail closure technique | Active comparator | Procedure: fishtail closure techniqueIn 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 |
| waisted tear drop | Active comparator | Procedure: closure technique waisted tear drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fishtail closure techniqueIn 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 or surgery | fishtail closure technique |
| closure technique waisted tear dropIn 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 | Procedure or surgery | waisted tear drop |
Primary outcome
cosmetic outcomes
Time frame: 1 YEAR
To assesc osmetic outcome in terms of correction of dog-ear deformity (Yes/No)
patient satisfaction
Time frame: 1 year
to assess patient satisfaction five-point Likert scale was used
3 secondary outcomes
Operative time
Time frame: 1 YEAR
wound healing
Time frame: 1 year
post operative complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 26776364Lim 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.
- Background: PubMed 23305050Thomas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fishtail closure technique and closure technique waisted tear drop in people with Closure Technique, run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cosmetic outcomes (time frame: 1 YEAR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07606482, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.