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

Last updated: July 4, 2025
Sponsor: Vastra Gotaland Region
Overall Status: Completed

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Deep inferior epigastric perforator flap

Thoracodorsal artery perforator flap to breast

Latissimus dorsi flap

Clinical Study ID

NCT04526561
254-18
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Patients eligible for breast reconstruction following mastectomy and radiation

  • Non-smokers or ex-smokers (>6 weeks)

  • BMI < 30

Exclusion

Exclusion Criteria:

  • Inability to leave informed consent

  • Inability to understand Swedish

  • Previous surgery with scaring on back

Study Design

Total Participants: 550
Treatment Group(s): 3
Primary Treatment: Deep inferior epigastric perforator flap
Phase:
Study Start date:
August 01, 2020
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Sahlgrenska university hospital

    Gothenburg, 413 45
    Sweden

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.