Leg Coverage DefectsNCT05864963
Medial Tab Flap for Soft Tissue Defects of the Leg
An observational study of Leg Coverage Defects, run by Fundación Campbell at 1 site in Colombia.
Trial summary
Selecting the right technique for lower limb soft tissue reconstruction is a therapeutic challenge. Despite having several reconstruction options, it's important to choose a technique that is effective and with the least possible donor site morbidity for the patient. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Leg Coverage Defects
- What is being tested?
- Medial tab-type fasciocutaneous flap
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteColombia
- Study dates
- 20 Jan 2019to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 216 patients with soft tissue defects on the anterior aspect of the leg underwent surgery during the study period, of these 18 patients were treated with medial tab-type fasciocutaneous flaps, this group constituted the intervention group. 198 underwent surgery with conventional flaps, of which 46 patients were randomly chosen, through Propensity Score Matching (PSM) the matching was performed with the age variable. The types of flaps considered were: 15 cases with sural flap, 18 with soleus flap, and 13 with a gastrocnemius flap
Who may be able to join
- diagnosis of soft tissue defects in the leg due to grade III B open fractures, or due to bone infection
- contraindication to using conventional flaps due to the following reasons: soft tissue injuries at the flap island site, injury to the vascular bed of the flap or injury of the flap structure (fascia, skin or muscle)
- people between 18 and 70 years of age
Who cannot join
- Patients with a history of free flaps
- Whose clinical follow up couldn't be completed to assess outcomes were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medial Tab-type Fasciocutaneous Flap as an Alternative for the Management of Soft Tissue Defects of the Leg
Selecting the right technique for lower limb soft tissue reconstruction is a therapeutic challenge. Despite having several reconstruction options, it's important to choose a technique that is effective and with the least possible donor site morbidity for the patient.
Objective: demonstrate the therapeutic efficacy of the medial tab flap in soft tissue reconstruction on the leg, compared to conventional flaps.
Materials and methods: Cohort study matched with Propensity Score Matching (PSM) by age. 64 patients with soft tissue defects were selected and followed up to one year postoperatively. Outcome variables: surgical time in minutes, healing, healing time in days, complications.
- Conditions
- Leg Coverage Defects
- Being tested
- Medial tab-type fasciocutaneous flap
- Keywords
- Lower extremity reconstruction, leg coverage defects, fasciocutaneous flaps, muscular flaps, orthoplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial tab-type fasciocutaneous flapProcedure or surgery
The flap can be taken in different ways depending on the defect. Once the base of the flap is identified, the posterior edge of the tibia is taken as reference; marking of the tab is performed considering that the posterior incision is located 5 cm from the posterior edge of the tibia, and the anterior incision is located longitudinally of the medial region of the tibial diaphysis, the length of the incision depends on the base of the flap and the defect's size.
The posterior incision is made first in the skin, subcutaneous cellular tissue until the fascia is identified; the subfascial flap is dissected to avoid injuring perforators, dissection is completed up to the anterior edge of the flap, if needed direct cutaneous perforators are ligated; once the subfascial plane has been identified and dissected, the tab is completed in its proximal or distal part according to the previous surgical planning. Later, the tab is rotated to the anterior region of the tibia to cover the defect.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | 18 patients treated with medial tab-type fasciocutaneous flaps Receives: Procedure: Medial tab-type fasciocutaneous flap | |
| Control group | 46 patients were randomly chosen, through Propensity Score Matching (PSM) the matching was performed with the age variable. The types of flaps considered were: 15 cases with sural flap, 18 with soleus flap, and 13 with a gastrocnemius flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in surgical and healing time between medial tab flaps and conventional flaps
This information was taken from he Sculapio software clinical records, the surgical time was measured in minutes from the moment of the incision to the clousure of the surgical planes, and the healing time was measured in days from the immediate postoperative period until the wound epithelization
Measured: January 2019 - December 2022
Secondary outcomes (2)
Sociodemographic and clinical characteristics
The data collection was made from the Sculapio software clinical records of the Fundacion Campbell
Measured: January 2019 - December 2022
Complications
The complications were descripted from the clinic history recorded by the orthopedic surgeon specialist, the following pathologies were taken into account: necrosis, suture dehiscence, fistula, foreign body granuloma, enlargement of the defect and infection.
Measured: January 2019 - December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start20 Jan 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Leg Coverage DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Campbell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864963
- Sponsor's protocol ID
- FC05052023
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh A, Jiong Hao JT, Wei DT, Liang CW, Murphy D, Thambiah J, Han CY. Gustilo IIIB Open Tibial Fractures: An Analysis of Infection and Nonunion Rates. Indian J Orthop. 2018 Jul-Aug;52(4):406-410. doi: 10.4103/ortho.IJOrtho_369_16.
PubMed 30078900Parrett Brian M, Pribaz Julian J. Reconstrucción de extremidad inferior. Rev Médica Clínica Las Condes. 2010;21(1):76-85
Rodríguez Lara JN, Ochoa Fletes MP. Serie de casos: colgajo sóleo-gastrocnemio en pacientes con defectos de partes blandas en miembros inferiores. Rev Med Hondur. 2021;89(2):131-6
Martinov M, Argirova M. Fasciocutaneous flaps in the lower limb soft tissue reconstruction - A surgical case series. Orthoplastic Surg [Internet]. 2022;9(May):1-8. Available from: https://doi.org/10.1016/j.orthop.2022.05.002
Friedrich JB, Katolik LI, Hanel DP. Reconstruction of soft-tissue injury associated with lower extremity fracture. J Am Acad Orthop Surg. 2011 Feb;19(2):81-90. doi: 10.5435/00124635-201102000-00003.
PubMed 21292931Vergara-amador E. El uso de colgajos en la reconstrucción de defectos de cobertura en la pierna distal y dorso de pie The use of flaps in the reconstruction of defects of coverage in the distal leg and dorsum of the foots. 2013;29(1):74-82.
MacKechnie MC, Flores MJ, Giordano V, Terry MJ, Garuz M, Lee N, Padilla Rojas LG, MacKechnie MA, Bidolegui F, Brown K, Quintero JE, Ding A, Sanchez Valenciano CG, Tabares Neyra H, Segovia J, Aguilar D, van Lieshout EM, Verhofstad MH, Miclau T. Management of soft-tissue coverage of open tibia fractures in Latin America: Techniques, timing, and resources. Injury. 2022 Apr;53(4):1422-1429. doi: 10.1016/j.injury.2022.01.027. Epub 2022 Jan 19.
PubMed 35101259Taylor GI, Palmer JH. The vascular territories (angiosomes) of the body: experimental study and clinical applications. Br J Plast Surg. 1987 Mar;40(2):113-41. doi: 10.1016/0007-1226(87)90185-8.
PubMed 3567445Attinger CE, Evans KK, Bulan E, Blume P, Cooper P. Angiosomes of the foot and ankle and clinical implications for limb salvage: reconstruction, incisions, and revascularization. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):261S-293S. doi: 10.1097/01.prs.0000222582.84385.54.
PubMed 16799395Concha JM, Camaro PL, David A, Concha C. The lateral supramalleolar flap for the treatment of open foot and ankle fractures. Orthoplastic Surg [Internet]. 2022;9(May):80-5. Available from: https://doi.org/10.1016/j.orthop.2022.07.006
Mahajan RK, Srinivasan K, Singh M, Jain A, Kapadia T, Tambotra A. Management of Post-Traumatic Composite Bone and Soft Tissue Defect of Leg. Indian J Plast Surg. 2019 Jan;52(1):45-54. doi: 10.1055/s-0039-1688097. Epub 2019 May 8.
PubMed 31456612Luo Z, Dong Z, Ni J, Wei J, Peng P, Lv G. Distally Based Peroneal Artery Perforator-Plus Fasciocutaneous Flap to Reconstruct Soft Tissue Defect Combined With Chronic Osteomyelitis in the Lateral Malleolus. Int J Low Extrem Wounds. 2022 Dec;21(4):464-470. doi: 10.1177/1534734620956782. Epub 2020 Sep 11.
PubMed 32912022Akhtar S, Hameed A. Versatility of the sural fasciocutaneous flap in the coverage of lower third leg and hind foot defects. J Plast Reconstr Aesthet Surg. 2006;59(8):839-45. doi: 10.1016/j.bjps.2005.12.009. Epub 2006 Mar 9.
PubMed 16876082Economides JM, DeFazio MV, Golshani K, Cinque M, Anghel EL, Attinger CE, Evans KK. Systematic Review and Comparative Meta-Analysis of Outcomes Following Pedicled Muscle versus Fasciocutaneous Flap Coverage for Complex Periprosthetic Wounds in Patients with Total Knee Arthroplasty. Arch Plast Surg. 2017 Mar;44(2):124-135. doi: 10.5999/aps.2017.44.2.124. Epub 2017 Mar 15.
PubMed 28352601Zweifel-Schlatter M, Haug M, Schaefer DJ, Wolfinger E, Ochsner P, Pierer G. Free fasciocutaneous flaps in the treatment of chronic osteomyelitis of the tibia: a retrospective study. J Reconstr Microsurg. 2006 Jan;22(1):41-7. doi: 10.1055/s-2006-931906.
PubMed 16425121
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Tab-type Fasciocutaneous Flap as an Alternative for the Management of Soft Tissue Defects of the Leg
- ClinicalTrials.gov ID
- NCT05864963
- Acronym / sponsor ID
- FC05052023
- Conditions
- Leg Coverage Defects
- Keywords
- Lower extremity reconstruction, leg coverage defects, fasciocutaneous flaps, muscular flaps, orthoplastic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fundación CampbellUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Selecting the right technique for lower limb soft tissue reconstruction is a therapeutic challenge. Despite having several reconstruction options, it's important to choose a technique that is effective and with the least possible donor site morbidity for the patient.
Objective: demonstrate the therapeutic efficacy of the medial tab flap in soft tissue reconstruction on the leg, compared to conventional flaps.
Materials and methods: Cohort study matched with Propensity Score Matching (PSM) by age. 64 patients with soft tissue defects were selected and followed up to one year postoperatively. Outcome variables: surgical time in minutes, healing, healing time in days, complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Procedure: Medial tab-type fasciocutaneous flap18 patients treated with medial tab-type fasciocutaneous flaps |
| Control group | – | –46 patients were randomly chosen, through Propensity Score Matching (PSM) the matching was performed with the age variable. The types of flaps considered were: 15 cases with sural flap, 18 with soleus flap, and 13 with a gastrocnemius flap |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 216 patients with soft tissue defects on the anterior aspect of the leg underwent surgery during the study period, of these 18 patients were treated with medial tab-type fasciocutaneous flaps, this group constituted the intervention group. 198 underwent surgery with conventional flaps, of which 46 patients were randomly chosen, through Propensity Score Matching (PSM) the matching was performed with the age variable. The types of flaps considered were: 15 cases with sural flap, 18 with soleus flap, and 13 with a gastrocnemius flap
Key inclusion criteria (3 listed)
- diagnosis of soft tissue defects in the leg due to grade III B open fractures, or due to bone infection
- contraindication to using conventional flaps due to the following reasons: soft tissue injuries at the flap island site, injury to the vascular bed of the flap or injury of the flap structure (fascia, skin or muscle)
- people between 18 and 70 years of age
Key exclusion criteria (2 listed)
- Patients with a history of free flaps
- Whose clinical follow up couldn't be completed to assess outcomes were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medial tab-type fasciocutaneous flapThe flap can be taken in different ways depending on the defect. Once the base of the flap is identified, the posterior edge of the tibia is taken as reference; marking of the tab is performed considering that the posterior incision is located 5 cm from the posterior edge of the tibia, and the anterior incision is located longitudinally of the medial region of the tibial diaphysis, the length of the incision depends on the base of the flap and the defect's size. The posterior incision is made first in the skin, subcutaneous cellular tissue until the fascia is identified; the subfascial flap is dissected to avoid injuring perforators, dissection is completed up to the anterior edge of the flap, if needed direct cutaneous perforators are ligated; once the subfascial plane has been identified and dissected, the tab is completed in its proximal or distal part according to the previous surgical planning. Later, the tab is rotated to the anterior region of the tibia to cover the defect. | Procedure or surgery | Intervention group |
Primary outcome
Differences in surgical and healing time between medial tab flaps and conventional flaps
Time frame: January 2019 - December 2022
This information was taken from he Sculapio software clinical records, the surgical time was measured in minutes from the moment of the incision to the clousure of the surgical planes, and the healing time was measured in days from the immediate postoperative period until the wound epithelization
2 secondary outcomes
Sociodemographic and clinical characteristics
Time frame: January 2019 - December 2022
Complications
Time frame: January 2019 - December 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 30078900Singh A, Jiong Hao JT, Wei DT, Liang CW, Murphy D, Thambiah J, Han CY. Gustilo IIIB Open Tibial Fractures: An Analysis of Infection and Nonunion Rates. Indian J Orthop. 2018 Jul-Aug;52(4):406-410. doi: 10.4103/ortho.IJOrtho_369_16.
- BackgroundParrett Brian M, Pribaz Julian J. Reconstrucción de extremidad inferior. Rev Médica Clínica Las Condes. 2010;21(1):76-85
- BackgroundRodríguez Lara JN, Ochoa Fletes MP. Serie de casos: colgajo sóleo-gastrocnemio en pacientes con defectos de partes blandas en miembros inferiores. Rev Med Hondur. 2021;89(2):131-6
- BackgroundMartinov M, Argirova M. Fasciocutaneous flaps in the lower limb soft tissue reconstruction - A surgical case series. Orthoplastic Surg [Internet]. 2022;9(May):1-8. Available from: https://doi.org/10.1016/j.orthop.2022.05.002
- Background: PubMed 21292931Friedrich JB, Katolik LI, Hanel DP. Reconstruction of soft-tissue injury associated with lower extremity fracture. J Am Acad Orthop Surg. 2011 Feb;19(2):81-90. doi: 10.5435/00124635-201102000-00003.
- BackgroundVergara-amador E. El uso de colgajos en la reconstrucción de defectos de cobertura en la pierna distal y dorso de pie The use of flaps in the reconstruction of defects of coverage in the distal leg and dorsum of the foots. 2013;29(1):74-82.
- Background: PubMed 35101259MacKechnie MC, Flores MJ, Giordano V, Terry MJ, Garuz M, Lee N, Padilla Rojas LG, MacKechnie MA, Bidolegui F, Brown K, Quintero JE, Ding A, Sanchez Valenciano CG, Tabares Neyra H, Segovia J, Aguilar D, van Lieshout EM, Verhofstad MH, Miclau T. Management of soft-tissue coverage of open tibia fractures in Latin America: Techniques, timing, and resources. Injury. 2022 Apr;53(4):1422-1429. doi: 10.1016/j.injury.2022.01.027. Epub 2022 Jan 19.
- Background: PubMed 3567445Taylor GI, Palmer JH. The vascular territories (angiosomes) of the body: experimental study and clinical applications. Br J Plast Surg. 1987 Mar;40(2):113-41. doi: 10.1016/0007-1226(87)90185-8.
- Background: PubMed 16799395Attinger CE, Evans KK, Bulan E, Blume P, Cooper P. Angiosomes of the foot and ankle and clinical implications for limb salvage: reconstruction, incisions, and revascularization. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):261S-293S. doi: 10.1097/01.prs.0000222582.84385.54.
- BackgroundConcha JM, Camaro PL, David A, Concha C. The lateral supramalleolar flap for the treatment of open foot and ankle fractures. Orthoplastic Surg [Internet]. 2022;9(May):80-5. Available from: https://doi.org/10.1016/j.orthop.2022.07.006
- Background: PubMed 31456612Mahajan RK, Srinivasan K, Singh M, Jain A, Kapadia T, Tambotra A. Management of Post-Traumatic Composite Bone and Soft Tissue Defect of Leg. Indian J Plast Surg. 2019 Jan;52(1):45-54. doi: 10.1055/s-0039-1688097. Epub 2019 May 8.
- Background: PubMed 32912022Luo Z, Dong Z, Ni J, Wei J, Peng P, Lv G. Distally Based Peroneal Artery Perforator-Plus Fasciocutaneous Flap to Reconstruct Soft Tissue Defect Combined With Chronic Osteomyelitis in the Lateral Malleolus. Int J Low Extrem Wounds. 2022 Dec;21(4):464-470. doi: 10.1177/1534734620956782. Epub 2020 Sep 11.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leg Coverage Defects, run by Fundación Campbell at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in surgical and healing time between medial tab flaps and conventional flaps (time frame: January 2019 - December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05864963, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.