NCT Number: NCT04687345
Lateral Supramalleolar Perforator Flap Reconstruction Through Branches Outside of the Ankle Tissue Defects
The lateral ankle is a common site of tissue defects and the defects in this area are often accompanied by exposure of the fibula and tendons. Microsurgical tissue transfer or a pedicled flap is needed to cover those exposures for even a relatively small defect due to the insufficiency of the local cutaneous and muscle flap in this area. Koshima et al. and Wei et al. began to propose the concept of localized perforator flaps, which were initially applied to free perforator flaps. The main benefits of such localized perforator flaps are described below.
1. It preserves vital blood vessels and the underlying muscles and fascia. 2. Complications in the donor area are rare and can be direct or partial sutures. 3. Not technically demanding, although we need to find the vessel but not the vessel junction. 4. Shorter surgery time.
There are many choices of perforator flaps for lateral ankle soft tissue defects, including lateral upper ankle flap, retrograde anterior tibial artery flap, retrograde gastrocnemius flap, etc. Among them, the lateral upper ankle flap is one of the flaps commonly used for reconstruction of lateral ankle tissue defects, and the research on the lateral upper peroneal artery perforator flap is limited.
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Conditions
Age range
20 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
The purpose of this study is to evaluate the clinical application of the peroneal artery perforator flap with or without split-thickness skin grafting for soft tissue reconstruction of the bony defect of the lateral malleolus of the ankle joints. Reconstruction using a peroneal artery perforator flap with or without split-thickness skin grafting was performed for 10 men and 5 women patients with defects in the lateral malleolus. The mean age was 53.7 years with the age range between 22 and 89 years, and the mean size of the flaps was 40 cm^2. The soft tissue defects were caused by a diabetic foot (6 patients), infected bursitis (1 patient), chronic osteomyelitis (2 patients), and trauma (6 patients). Three of six diabetes mellitus patients also had peripheral arterial occlusive disease. The flaps were elevated in the form of a perforator flap, and split-thickness skin grafting was performed over the flaps and adjoining raw areas. The pedicled supramalleolar perforator flap is classified into two categories: (A) propeller and (B) rotation flaps. The mean follow-up duration was 30 months postsurgical.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- The subject is aged 20 years old or above (including 20 years old), regardless of gender.
- Patients with lateral ankle tissue defects
Exclusion criteria
- The subject is aged under 20 years old.
- Patients with tissue metabolic disorders, immune dysfunction, and drug abuse.
- Patients with severe primary diseases or mental illness such as those involving the hematopoietic system, endocrine system, etc.
- Pregnant and lactating women.
- Patient who is unwilling or unable to cooperate with the trial process or follow medical advice.
Treatment and study plan
Primary outcomes
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Perforator flap type
Time frame: 3-60 months
The type of the flap is categorized into propeller and rotation flap. It is determined according to the distance between the perforator and the tip of the lateral malleolus. A distance of less than 2 cm used rotation-type perforator flap, while for a distance of greater than 2 cm would use propeller-type.
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Flap size
Time frame: 3-60 months
The flap size is measured in the unit of cm^2. The flap size ranged from 4 cm × 3 cm to 16 cm × 6 cm.
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Distance between the perforator and the tip of the lateral malleolus
Time frame: 3-60 months
The distances of all perforators from the wound, which is the tip of the lateral malleolus in this study, were measured in the unit of cm. The distance ranged from 2 cm to 5 cm.
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Complication status
Time frame: 3-60 months
The complication status expresses the complication that occurred during the wound reconstruction. The status is stated as no complication (N) and the complication happened to the patients, such as "partial flap necrosis".
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Follow-up month
Time frame: 3-60 months
The follow-up month indicates the duration and the follow-up of the wound reconstruction.
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Donor site type
Time frame: 3-60 months
The donor site type indicates the type of skin grafting needed to be applied for covering the donor site of the patients. The donor site type in this study is divided into split-thickness skin grafting (STSG) and primary closure. The STSG was applied to 12 patients, whereas the primary closure was conducted on 3 patients.
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Result status
Time frame: 3-60 months
The success of the reconstruction processes is stated in the result status. All flaps and skin graftings survived which implies all wound reconstructions were successful.
Sponsors and collaborators
Lead sponsor
National Defense Medical Center, Taiwan
Other
Registry information
Official study title
Clinical Research of Using Lateral Supramalleolar Perforator Flap Reconstruction Through Branches Outside of the Ankle Tissue Defects
Important dates
- Study start
- 2007
- Primary completion
- 2016
- Study completion
- 2018
- First posted
- Dec 29, 2020
- Registry last updated
- Dec 29, 2020
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.