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Enrolling by Invitation

NCT Number: NCT06258863

Investigating the Effects of Different Incision Types on Aesthetic Outcomes and Incision-related Complications After Breast Reconstruction Surgery

1. DATA COLLECTION: About 300 cases of female patients who underwent breast reconstruction at Hubei Cancer Hospital(HBCH) between February 2013 and June 2023 were retrospectively collected. The incision was defined as the mastectomy incision and was grouped by the commonly used inframammary fold incision, lateral chest wall incision, circumareolar incision, and radial incision. The incidence of postoperative incision-related complications was recorded for different incision types; 2. DATA ORGANIZATION: Patients were divided into subgroups based on history of previous breast surgery, location and size of the lump, retention of the nipple-areola complex, timing of reconstruction, and type of the implant. The correlation of each subgroup with incision design is discussed; 3. FOLLOW-UP: Collected cases were followed up by telephone to complete the Breast-Q questionnaire (aesthetic score); 4. DATA ANALYSIS: The incidence of postoperative incision-related complications and aesthetic scores for different incision types were statistically analyzed.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hubei Cancer Hospital

Wuhan, Hongshan District, 430070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • total mastectomy
  • implant and/or autologous breast reconstruction.

Exclusion criteria

  • No total mastectomy
  • loss of data or loss of follow-up
  • fatal cases

Treatment and study plan

incision type

Procedure

Total mastectomy was performed using one of the four incision types

Primary outcomes

  1. Breast-Q Version 2.0 Reconstruction Module

    Time frame: three months after surgery; six months after surgery; 1 year after surgery

    The questionnaire was filled in by the subjects, and the researchers assigned scores according to the results of the questionnaire. scores of the following three parts were recorded according to the Breast-Q Version 2.0© reconstruction module, with higher scores indicating better aesthetic results, Psychosocial Well-being (0 to 100), Sexual Well-being (0 to 100), Satisfaction with Breasts (0 to 100)

Secondary outcomes

  1. Incision-Related Complications

    Time frame: within 1 year after surgery

    The researchers followed up the patients closely after surgery, and recorded the incidence of different postoperative incision complications of the subjects, such as infection, seroma, incision dehiscence, and capsular contracture.

Sponsors and collaborators

Lead sponsor

Hubei Cancer Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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