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

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ClinicalTrials.gov Identifier: NCT04526561
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Hidradenitis Suppurativa Procedure: Thoracodorsal artery perforator flap (TDAP) to axilla Procedure: Latissimus dorsi flap Procedure: Thoracodorsal artery perforator flap (TDAP) to breast Procedure: Limberg flap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Active Comparator: Hidradenitis suppurativa TDAP
Axillary hidradenitis suppurativa reconstructed with TDAP
Procedure: Thoracodorsal artery perforator flap (TDAP) to axilla
Reconstruction of axillary hidradenitis suppurativa

Active Comparator: Hidradenitis suppurativa Limberg
Axillary hidradenitis suppurativa reconstructed with a Limberg flap
Procedure: Limberg flap
Reconstruction of axillary hidradenitis suppurativa

Active Comparator: Breast reconstruction TDAP
Breast reconstruction performed with TDAP
Procedure: Latissimus dorsi flap
Breast reconstruction

Active Comparator: Breast reconstruction latissimus dorsi
Breast reconstruction performed with latissimus dorsi
Procedure: Thoracodorsal artery perforator flap (TDAP) to breast
Breast reconstruction




Primary Outcome Measures :
  1. Satisfaction after breast reconstruction with latissimus dorsi reconstruction [ Time Frame: 10 years ]
    Breast Q reconstruction.The BREAST-Q has multiple domains, each scored from 0 to 100 (higher scores indicate greater satisfaction or quality of life), there is no overall BREAST-Q score.

  2. Back and shoulder function after breast reconstruction with latissimus dorsi reconstruction [ Time Frame: 10 years ]
    Breast Q the back and shoulder function scale. The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

  3. Back appearance after breast reconstruction with latissimus dorsi reconstruction [ Time Frame: 10 years ]
    Breast-Q the back appearance scale.The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

  4. Satisfaction after breast reconstruction with TDAP [ Time Frame: 2 years ]
    Breast Q reconstruction.The BREAST-Q has multiple domains, each scored from 0 to 100 (higher scores indicate greater satisfaction or quality of life), there is no overall BREAST-Q score.

  5. Back appearance after breast reconstruction with TDAP [ Time Frame: 2 years ]
    Breast Q back appearance scale.The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

  6. Back and shoulder function after breast reconstruction with TDAP [ Time Frame: 2 years ]
    Breast Q back and shoulder function. The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

  7. Generic health-status after breast reconstruction with TDAP [ Time Frame: 2 years ]
    EuroQol-5 (EQ5D) has two components health state description and evaluation.health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It has five levels of severity: having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems. It can define 3,125 (=55) different health states. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (0-100). A higher scores indicate a better health-status

  8. Generic health-status after breast reconstruction with latissimus dorsi [ Time Frame: 2 years ]
    EuroQol-5 (EQ5D) has two components health state description and evaluation.health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It has five levels of severity: having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems. It can define 3,125 (=55) different health states. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (0-100). A higher scores indicate a better health-status

  9. Shoulder function after reconstruction of axillary hidradenitis suppurativa with a limberg flap [ Time Frame: 2 years ]
    Western Ontario Osteoarthritis of the shoulder index (WOOS) provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions.Each question has a possible score from 0-100 giving a total score up to 1900. The highest or most symptomatic score is 1900 and the best or asymptomatic score is 0.

  10. Shoulder function after reconstruction of axillary hidradenitis suppurativa with a TDAP [ Time Frame: 2 years ]
    Western Ontario Osteoarthritis of the shoulder index (WOOS) provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions.Each question has a possible score from 0-100 giving a total score up to 1900. The highest or most symptomatic score is 1900 and the best or asymptomatic score is 0.

  11. General health status after reconstruction of axillary hidradenitis suppurativa with a limberg flap. [ Time Frame: 2 years ]
    EuroQol-5 (EQ5D) has two components health state description and evaluation.health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It has five levels of severity: having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems. It can define 3,125 (=55) different health states. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (0-100). A higher scores indicate a better health-status

  12. General health status after reconstruction of axillary hidradenitis suppurativa with a TDAP [ Time Frame: 2 years ]
    EuroQol-5 (EQ5D) has two components health state description and evaluation.health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It has five levels of severity: having no problems, having slight problems, having moderate problems, having severe problems and being unable to do/having extreme problems. It can define 3,125 (=55) different health states. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (0-100). A higher scores indicate a better health-status


Secondary Outcome Measures :
  1. Complications after breast reconstruction [ Time Frame: 2 years ]
    Measured in patients randomized to TDAP or latissimus dorsi flap.

  2. Complications after reconstruction of hidradenitis suppurativa [ Time Frame: 2 years ]
    Measured in patients randomized to TDAP or a limberg flap.


Other Outcome Measures:
  1. Validation of Breast Q: The Back Appearance scale for Swedish [ Time Frame: 1 year ]
    Translation and validation of the instrument for Swedish

  2. Validation of Breast-Q: The back and shoulder function scale for Swedish [ Time Frame: 1 year ]
    Translation and validation of the instrument for Swedish

  3. Normal material for Breast-Q [ Time Frame: 5 years ]
    Measurement of quality of life according to breast-Q in a normative population

  4. Normal material for Breast-Q back appearance scale [ Time Frame: 5 years ]
    Measurement of quality of life according to breast-Q back appaearance scale in a normative population

  5. Normal material for Breast-Q back and shoulder function scale [ Time Frame: 5 years ]
    Measurement of quality of life according to breast-Q back and shoulder function scale in a normative population



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

-Patients eligible for breast reconstruction (radiated patients) or reconstruction for axillary hidradenitis suppurativa

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526561


Contacts
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Contact: Emma Hansson, PhD, MD +46313421000 emma.hansson.2@gu.se

Locations
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Sweden
Sahlgrenska university hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Emma Hansson, PhD    +46 31 342 10 00    emma.hansson.2@gu.se   
Sponsors and Collaborators
Vastra Gotaland Region
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT04526561    
Other Study ID Numbers: 254-18
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration