Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093999
• Other study ID #: METC 16 - 4 - 147
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients 18 years or older

• Unilateral or bilateral DIEP flap breast reconstruction

• Returned for follow-up between August 2016 and August 2019

• Informed consent

Exclusion Criteria:

• Total flap loss complication

• Flaps that required a take-back

• Follow-up less than six months postoperatively

• Only one postoperative measurement at less than 12 months follow-up

• Mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Sensory nerve coaptation
A recipient sensory nerve branch of the 11th-12th intercostal nerve was reattached to a donor nerve in the chest area. The anterior cutaneous branch of the second or third intercostal nerve was used as the donor nerve. Direct, end-to-end nerve coaptation was performed.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean monofilament value as a measure for the sensory recovery of the reconstructed breast	The sensory recovery of the breast to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Nine areas of the breast, indicating native skin and flap skin, were tested. Mean monofilament values were calculated for each area and compared between groups.	Through study completion up to 36 months postoperatively
Secondary	Mean monofilament value as a measure for the sensory recovery of the reconstructed breast	The sensory recovery of the donor site to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Four areas of the donor site were tested, two areas above and two areas below the scar. Mean monofilament values were calculated for the total donor site and compared between groups.	Through study completion up to 36 months postoperatively