Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales

Vastra Gotaland Region

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Deep inferior epigastric perforator flap; Procedure: Thoracodorsal artery perforator flap to breast; Procedure: Latissimus dorsi flap

Study type: Interventional

Funder types: Other

Identifiers

NCT04526561

254-18

Details and patient eligibility

About

The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts.

1. Validation of scales/instrument for Swedish.
2. Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up.
3. Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction.
4. TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.

Enrollment: 550 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients eligible for breast reconstruction following mastectomy and radiation
• Non-smokers or ex-smokers (>6 weeks)
• BMI < 30

Exclusion criteria

• Inability to leave informed consent
• Inability to understand Swedish
• Previous surgery with scaring on back

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 3 patient groups

Breast reconstruction TDAP

Active Comparator group

Description:

Breast reconstruction performed with TDAP

Treatment:

Procedure: Thoracodorsal artery perforator flap to breast

Breast reconstruction latissimus dorsi

Active Comparator group

Description:

Breast reconstruction performed with latissimus dorsi

Treatment:

Procedure: Latissimus dorsi flap

Breast reconstruction with DIEP

Active Comparator group

Description:

Breast reconstruction performed with a deep inferior epigastric artery perforator flap

Treatment:

Procedure: Deep inferior epigastric perforator flap