Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04533373
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2020-08-26
Brief Title:
Sensory Restoration After DIEP Flap Neurotization
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
The Effect of DIEP Flap Neurotization on Sensory Restoration After Breast Reconstruction
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Common goals of breast reconstruction include obtaining satisfactory breast symmetry softness and appropriate size and shape Advances in surgical techniques have prompted a new goal achieving breast sensation after reconstructive surgery This desire has led the surgical community to investigate operative techniques for achieving this goal However few studies have examined the effectiveness of breast sensory restoration
Sensory nerves are nerves responsible for sensation from skin When a sensory nerve is cut sensation is lost to the area supplied by the nerve In the case of Breast reconstruction this involves the nerves supplying the skin overlying breasts Neurotization refers to regeneration of the nerve after it has been cut This means that the cut nerve is being repaired in order to restore its function In Neurotization this repair is carried out using a new source In this case the investigators want to restore function of the nerves that supply the skin overlying the breasts
The investigators will be performing breast reconstruction using tissue from the patients abdomen and transferring it to the chest wall to repair the mastectomy defect Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue ie the new source that is being transferred and attaching it to a nerve in the chest wall
The Avance Nerve graft is a nerve graft material that has been produced by Axogen Inc The graft is made by processing donated human nerves This graft is used during neurotization to bridge the gap and join the nerve from the abdominal tissue to the nerve in the chest wall The use of the graft helps the body to attach these 2 nerves and improves nerve repair
When neurotization is done without the nerve graft there is a possibility that the surgeon may require extra nerve material to join the 2 nerves Traditionally in this case the surgeon would have to obtain a separate donor nerve from another part of the patients body This technique carries the risk of complications to part of the body that the separate donor nerve was obtained from - loss of sensation infection or neuroma formation an abnormal growth of nerve tissue that can cause pain burning or tingling sensation numbness The Avance nerve graft avoids the need for the additional donor nerve and the possible complications associated with it
The Avance Nerve Graft is currently being used in some women during breast reconstruction surgery however the effectiveness of this procedure in improving the restoration of sensation has not been proven
Women undergoing reconstruction of one breast and at the same time using the womens own tissue as part of standard clinical care may join
Sensory nerves are nerves responsible for sensation from skin When a sensory nerve is cut sensation is lost to the area supplied by the nerve In the case of Breast reconstruction this involves the nerves supplying the skin overlying breasts Neurotization refers to regeneration of the nerve after it has been cut This means that the cut nerve is being repaired in order to restore its function In Neurotization this repair is carried out using a new source In this case the investigators want to restore function of the nerves that supply the skin overlying the breasts
The investigators will be performing breast reconstruction using tissue from the patients abdomen and transferring it to the chest wall to repair the mastectomy defect Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue ie the new source that is being transferred and attaching it to a nerve in the chest wall
The Avance Nerve graft is a nerve graft material that has been produced by Axogen Inc The graft is made by processing donated human nerves This graft is used during neurotization to bridge the gap and join the nerve from the abdominal tissue to the nerve in the chest wall The use of the graft helps the body to attach these 2 nerves and improves nerve repair
When neurotization is done without the nerve graft there is a possibility that the surgeon may require extra nerve material to join the 2 nerves Traditionally in this case the surgeon would have to obtain a separate donor nerve from another part of the patients body This technique carries the risk of complications to part of the body that the separate donor nerve was obtained from - loss of sensation infection or neuroma formation an abnormal growth of nerve tissue that can cause pain burning or tingling sensation numbness The Avance nerve graft avoids the need for the additional donor nerve and the possible complications associated with it
The Avance Nerve Graft is currently being used in some women during breast reconstruction surgery however the effectiveness of this procedure in improving the restoration of sensation has not been proven
Women undergoing reconstruction of one breast and at the same time using the womens own tissue as part of standard clinical care may join
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None