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Absorbable Staples Versus Intracutaneous Butterfly Suture on Postoperative Scarring after Breast Reduction: Protocol for a Feasibility Randomized Controlled Trial

Absorbable Staples Versus Intracutaneous Butterfly Suture on Postoperative Scarring after Breast Reduction: Protocol for a Feasibility Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058792
Enrollment
Unknown
Registered
2022-04-17
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mastoptosis and hypermastia

Interventions

Group 1 :absorbable staples on the experimental side
Group 2:intracutaneous butterfly suture on the control side

Sponsors

Ang Zeng
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Between 18 and 60 years old; 2) The preoperative size and shape of bilateral breasts are symmetrical; 3) Diagnosed as macromastia, with excessive growth in breast volume, shoulder and back pain, respiratory distress, chest eczema dermatitis, lowered quality of life, and physical and mental struggle; 4) Presupposed operation procedures on the two breasts are the same; 5) Patients and their family members could understand the study protocol and are willing to participate in the study and agree to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Chronic diseases that could affect normal wound healing, such as diabetes, chronic kidney disease, malignant neoplasms, severe malnutrition, and so on; 2) History of hypertrophic scar or keloid; 3) Pregnant or lactating women; 4) Inability to return for the 12-month follow-up visit; 5) Unwillingness to provide informed consent; 6) Unilateral or asymmetric breast reduction (asymmetry is defined as the estimated length difference of bilateral wounds is larger than 5cm).

Design outcomes

Primary

MeasureTime frame
Patient and observer scar assessment scale (POSAS) ;

Secondary

MeasureTime frame
total operating time;subcuticular skin closure time;pain intensity using Visual Analog Scale (VAS);incision length;numbers of staples and stitches;costs;wound complications;

Countries

China

Contacts

Public ContactAng Zeng

Peking Union Medical College Hospital

zenga@pumch.cn+86 136 8350 7962

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026