Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324916
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2023-09-21
Brief Title:
Donor Site Morbidity After Free Vascularized Fibular Graft
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Long Term Evaluation Of Donor Site Morbidities After Free Vascularized Fibular Graft For Reconstruction Of Any Bone Defect Other Than In The Lower Limb
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This study was carried out at Assiut University to Asses the long-term donor site morbidity following free vascularized fibular transfer because there is a limited information regarding the long-term donor morbidity of this type of flap
Detailed Description:
There is a dearth of information on the long-term donor site morbility of free fibular flaps The recipient site can influence outcomes in the majority of research on donor site morbidity of free fibular grafting but in this study The invistigators will assess donor site morbidity and contrast the donor Leg with the contralateral Healthy one
Surgical method for free fibular flapTo reduce ankle instability the fibula was removed through lateral approach while the distal 5-7 cm of the bone was preserved To seal the wound at the donor location a full thickness or split thickness skin graft may be required a suction drain that is implanted prior to healing The donor leg was tightly covered with a bandage below the knee once the wound was closed Using a skin graft to seal the woundA gel foam pressure pack will be placed on top of an occlusive dressing if a skin transplant was utilized to seal the wound
postoperative patients management There was no difference in the postoperative care given to patients who had skin grafts at the donor location versus those who did not
The entries in the patients charts were used to evaluate postoperative wound healing at the donor site It was determined whether wound healing was simple or involved Dehiscence of wounds necrosis of soft tissuesPatients will be questioned about when they first started using crutches and when they stopped using them after surgery as well as when their ambulation returned to normal
They were questioned about their subjective current symptoms of discomfort pain and edema as well as about temperature differences sensory abnormalities motor function ie range of motion their ability to walk run ride a bike and climb stairs limitations on daily activities and their satisfaction with the donor legs scars appearance
During the physical examination in researchs the donor leg was compared to the unoperated leg for the following parameters strength and stability ability to stand and walk on tiptoe and heels with both legs with the unoperated and the operated leg and sensory evaluation in specific areas of the calf The latter included standardized examinations of pressure and touch perception with a standardized pressure probe and cotton swab respectivelythe big toe was most frequently involved with weakness both in flexion and extension The muscle stripping of EHL and FHL during the harvest of the fibula is probably responsible for the weakness
In this studythe invistigators will assess the outcomes and conduct data analysis to assess donor site morbidity and the benefits of surgery after free vascularized fibular transfer
Surgical method for free fibular flapTo reduce ankle instability the fibula was removed through lateral approach while the distal 5-7 cm of the bone was preserved To seal the wound at the donor location a full thickness or split thickness skin graft may be required a suction drain that is implanted prior to healing The donor leg was tightly covered with a bandage below the knee once the wound was closed Using a skin graft to seal the woundA gel foam pressure pack will be placed on top of an occlusive dressing if a skin transplant was utilized to seal the wound
postoperative patients management There was no difference in the postoperative care given to patients who had skin grafts at the donor location versus those who did not
The entries in the patients charts were used to evaluate postoperative wound healing at the donor site It was determined whether wound healing was simple or involved Dehiscence of wounds necrosis of soft tissuesPatients will be questioned about when they first started using crutches and when they stopped using them after surgery as well as when their ambulation returned to normal
They were questioned about their subjective current symptoms of discomfort pain and edema as well as about temperature differences sensory abnormalities motor function ie range of motion their ability to walk run ride a bike and climb stairs limitations on daily activities and their satisfaction with the donor legs scars appearance
During the physical examination in researchs the donor leg was compared to the unoperated leg for the following parameters strength and stability ability to stand and walk on tiptoe and heels with both legs with the unoperated and the operated leg and sensory evaluation in specific areas of the calf The latter included standardized examinations of pressure and touch perception with a standardized pressure probe and cotton swab respectivelythe big toe was most frequently involved with weakness both in flexion and extension The muscle stripping of EHL and FHL during the harvest of the fibula is probably responsible for the weakness
In this studythe invistigators will assess the outcomes and conduct data analysis to assess donor site morbidity and the benefits of surgery after free vascularized fibular transfer
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