Post Traumatic Skin Defect in Leg and FootNCT03269864
Use of Perforator Flaps for Leg and Foot Reconstruction
A study testing perforator flaps in people with Post Traumatic Skin Defect in Leg and Foot, run by Assiut University.
Trial summary
Perforator vessels are those where the source artery is deep and the branch that carries blood to the fasciocutaneous tissues passes through the overlying deep fascia. Soft tissue defects in the lower extremity, especially distal third of leg, present a challenge to reconstructive surgeons due to lack of reliable… Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Skin Defect in Leg and Foot
- What is being tested?
- perforator flaps
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2017to 1 Aug 2019
- Phase
- Interventional
- 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 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Traumatic soft tissue defects on foot and leg.
- Simple defects i.e., soft tissue loss, with or without, tendon injury.
- Patients from 6 years to 60 years old
Who cannot join
- Other causes of soft tissue defects e.g. (Diabetic, Vascular, post malignant resection).
- Complex defects (soft tissue with bone injury).
- Patients below 6 years or above 60 years old.
- Patients with debilitating diseases e.g chronic renal failure, diabetes mellitus….etc.
Trial locations and contacts
No sites are listed yet.
About this study
Perforator vessels are those where the source artery is deep and the branch that carries blood to the fasciocutaneous tissues passes through the overlying deep fascia.
Soft tissue defects in the lower extremity, especially distal third of leg, present a challenge to reconstructive surgeons due to lack of reliable local flaps, conventional reconstructive options include split skin grafting, local random fasciocutaneous flaps, cross leg fasciocutaneous flap, pedicled muscular or musculocutaneous flaps or microvascular free tissue transfer. All these procedures have their limitations and associated morbidity at donor site
Read the detailed description
Taylor and Palmer defined an angiosome as a three-dimensional vascular territory supplied by a source artery and vein through branches for all tissue layers between the skin and the bone, and showed that between neighboring angiosomes there are choked and true anastomotic arteries.
Koshima and Soeda in 1989, described an inferior epigastric artery skin flap without the rectus abdominis muscle for reconstruction of floor of mouth, began the era of perforator flaps.
The big popularity gained by the local perforator flaps was due to their main advantages: 1) Sparing of the source artery and underlying muscle and fascia, 2) Combining the very good blood supply of a musculocutaneous flap with the reduced donor-site morbidity of a skin flap, 3) Replacing like with like, 4) Limiting the donor-site to the same area, 5) Possibility of completely or partially primarily closure, 6) Technically less demanding, because they are microsurgical procedures, but without microvascular sutures, 7) Shorter operating time.
- Being tested
- perforator flaps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perforator flapsProcedure or surgery
40 patients with post traumatic skin defect at leg and foot will be managed by perforator flaps, 20 with pedicled perforator flaps and other 20 with free perforator flaps
| Study group | Role | What they receive |
|---|---|---|
| pedicled perforator flaps | Active comparator | Once the perforator is identified, the flap will be designed around the perforator or perforators according to the location and size of the defect.
A tourniquet is inflated without prior exsanguination. This maneuver facilitates identification of perforators as they remain filled with the blood.
An exploratory incision along the margin of flap is made keeping the position of marked perforator in mind. The incision is made through the skin, subcutaneous tissue, deep fascia (sub-fascial approach) and the perforator vessel is directly visualized. The incision is initially always made from one side of the flap only to properly identify the perforator.
Careful and meticulous dissection is done in a blunt way isolating the perforator.
After deflation of the tourniquet, hemostasis is performed. Receives: Procedure: perforator flaps |
| free perforator flaps | Active comparator | A two-team approach is used for microvascular free tissue transfer. The first team starts exploring the limb for the recipient vessel. The second team simultaneously begins elevating the perforator flap and its vascular pedicle.
Microvascular anastomosis will be carried out under operating microscope for one artery and one or two accompanying veins. Receives: Procedure: perforator flaps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the perforator flap
The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering).
Measured: This will be assessed in the first week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start5 Sep 2017 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Skin Defect in Leg and FootStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two arms, one will be managed by pedicled perforator flaps the other will be managed by free perforator flaps
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Adel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269864
- Sponsor's protocol ID
- 17200122
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Perforator Flaps for Leg and Foot Reconstruction
- ClinicalTrials.gov ID
- NCT03269864
- Acronym / sponsor ID
- 17200122
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Sep 2017 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 1 Sep 2017 (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.
Perforator vessels are those where the source artery is deep and the branch that carries blood to the fasciocutaneous tissues passes through the overlying deep fascia.
Soft tissue defects in the lower extremity, especially distal third of leg, present a challenge to reconstructive surgeons due to lack of reliable local flaps, conventional reconstructive options include split skin grafting, local random fasciocutaneous flaps, cross leg fasciocutaneous flap, pedicled muscular or musculocutaneous flaps or microvascular free tissue transfer. All these procedures have their limitations and associated morbidity at donor site
Detailed description
Taylor and Palmer defined an angiosome as a three-dimensional vascular territory supplied by a source artery and vein through branches for all tissue layers between the skin and the bone, and showed that between neighboring angiosomes there are choked and true anastomotic arteries.
Koshima and Soeda in 1989, described an inferior epigastric artery skin flap without the rectus abdominis muscle for reconstruction of floor of mouth, began the era of perforator flaps.
The big popularity gained by the local perforator flaps was due to their main advantages: 1) Sparing of the source artery and underlying muscle and fascia, 2) Combining the very good blood supply of a musculocutaneous flap with the reduced donor-site morbidity of a skin flap, 3) Replacing like with like, 4) Limiting the donor-site to the same area, 5) Possibility of completely or partially primarily closure, 6) Technically less demanding, because they are microsurgical procedures, but without microvascular sutures, 7) Shorter operating time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two arms, one will be managed by pedicled perforator flaps the other will be managed by free perforator flaps
| Arm | Type | Receives |
|---|---|---|
| pedicled perforator flaps | Active comparator | Procedure: perforator flapsOnce the perforator is identified, the flap will be designed around the perforator or perforators according to the location and size of the defect. A tourniquet is inflated without prior exsanguination. This maneuver facilitates identification of perforators as they remain filled with the blood. An exploratory incision along the margin of flap is made keeping the position of marked perforator in mind. The incision is made through the skin, subcutaneous tissue, deep fascia (sub-fascial approach) and the perforator vessel is directly visualized. The incision is initially always made from one side of the flap only to properly identify the perforator. Careful and meticulous dissection is done in a blunt way isolating the perforator. After deflation of the tourniquet, hemostasis is performed. |
| free perforator flaps | Active comparator | Procedure: perforator flapsA two-team approach is used for microvascular free tissue transfer. The first team starts exploring the limb for the recipient vessel. The second team simultaneously begins elevating the perforator flap and its vascular pedicle. Microvascular anastomosis will be carried out under operating microscope for one artery and one or two accompanying veins. |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Traumatic soft tissue defects on foot and leg.
- Simple defects i.e., soft tissue loss, with or without, tendon injury.
- Patients from 6 years to 60 years old
Key exclusion criteria (4 listed)
- Other causes of soft tissue defects e.g. (Diabetic, Vascular, post malignant resection).
- Complex defects (soft tissue with bone injury).
- Patients below 6 years or above 60 years old.
- Patients with debilitating diseases e.g chronic renal failure, diabetes mellitus….etc.
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 |
|---|---|---|
| perforator flaps40 patients with post traumatic skin defect at leg and foot will be managed by perforator flaps, 20 with pedicled perforator flaps and other 20 with free perforator flaps | Procedure or surgery | free perforator flaps, pedicled perforator flaps |
Primary outcome
Assessment of the perforator flap
Time frame: This will be assessed in the first week postoperative
The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing perforator flaps in people with Post Traumatic Skin Defect in Leg and Foot, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youssef Saleh Hassan, prof (01001166118 ext. 002, plasticclinic66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the perforator flap (time frame: This will be assessed in the first week postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2017.