Ankle Tissue Injury Wound Clinical Trial
Official title:
Clinical Research of Using Lateral Supramalleolar Perforator Flap Reconstruction Through Branches Outside of the Ankle Tissue Defects
| Verified date | December 2020 |
| Source | National Defense Medical Center, Taiwan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | December 12, 2018 |
| Est. primary completion date | December 12, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Defense Medical Center, Taiwan |
Hallock GG. Distal lower leg local random fasciocutaneous flaps. Plast Reconstr Surg. 1990 Aug;86(2):304-11. — View Citation
Koshima I, Itoh S, Nanba Y, Tsutsui T, Takahashi Y. Medial and lateral malleolar perforator flaps for repair of defects around the ankle. Ann Plast Surg. 2003 Dec;51(6):579-83. — View Citation
Wei FC, Seah CS, Tsai YC, Liu SJ, Tsai MS. Fibula osteoseptocutaneous flap for reconstruction of composite mandibular defects. Plast Reconstr Surg. 1994 Feb;93(2):294-304; discussion 305-6. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Perforator flap type | 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. | 3-60 months | |
| Primary | Flap size | 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. | 3-60 months | |
| Primary | Distance between the perforator and the tip of the lateral malleolus | 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. | 3-60 months | |
| Primary | Complication status | 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". | 3-60 months | |
| Primary | Follow-up month | The follow-up month indicates the duration and the follow-up of the wound reconstruction. | 3-60 months | |
| Primary | Donor site type | 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. | 3-60 months | |
| Primary | Result status | 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. | 3-60 months |