Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06324916

Donor Site Morbidity After Free Vascularized Fibular Graft

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university

Asyut, Egypt

Location status: Recruiting

About this study

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 wound.A 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 tissues,Patients 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 (i.e., range of motion), their ability to walk, run, ride a bike, and climb stairs, limitations on daily activities, and their satisfaction with the donor leg's scar's 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, respectively),the 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 study,the invistigators will assess the outcomes and conduct data analysis to assess donor site morbidity and the benefits of surgery after free vascularized fibular transfer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients done FVFG for reconstruction of bone defect other than lower limb bone defect.
  • surgery done >2yrs
  • Patient age > 18 yrs old

Exclusion criteria

Patient age < 18 Surgery done< 2yrs FVFG for reconstruction of lower limb bone defct Amputated other leg : Above Ankle Amputaion Double FVFG Fracture of the other leg side : Fracture Tibia, Fibula, Ankle Paraplegic patients

Treatment and study plan

Xray

Radiation

X rays for ankle to see distal fibular remenant

Primary outcomes

  1. Donor site morbidity in contrast with surgery benifits this will be measured by point evaluation system

    Time frame: Two years after surgery

    in the point evaluation system patients filled out a questionnaire about the donor site scar, function loss, wound healing, complications, and pain. A total morbidity score was developed based on these items using a point rating system.

Study contacts

Contact information is provided by the study sponsor or research team.

Hedra Rafat Ishak

CONTACT

[email protected]

00201069557727

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.