CompletedPhase 3

Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss

France72 participantsStarted 2009-06

Plain-language summary

Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery.

Who can participate

Age range

15 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patient with skin loss traumatic or chronic wound * wound located from mid third of the leg to distal extremity of feet * with muscle and/or tendon and/or bone and/or articulation exposure * requiring a first surgical intervention for the coverage of the skin loss * patient eligible to the Integra® surgery techniques * patient with social security affiliation * written informed consent signed by the patient or representative Exclusion Criteria: * Bone fracture located in the skin loss * Non traumatic wound * Wound with muscle exposure only * Immunocompromised patient * Allergy to bovine collagen, glycosaminoglycans or silicon * patient with an healthstate that compromise the 18 months Follow-up * pregnant women / who intend to become pregnant within the 18 months of follow-up * Patient under administrative or legal supervision

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of at least one complication requiring a surgical re-intervention

Timeframe: Within the first 18 months after surgery

Persistence of an important / major trouble of the scar measured by a "scar-trouble scale" filled in by the patient.

Timeframe: at 18 month-follow up

Auto-evaluation of patient's scar esthetical result with a visual analog scale.

Timeframe: at 18 month-follow up

Trial details

NCT IDNCT00906672

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01

View on ClinicalTrials.gov More Leg Injuries trials

Who can participate

Age range

15 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Occurrence of at least one complication requiring a surgical re-intervention

Timeframe: Within the first 18 months after surgery

Persistence of an important / major trouble of the scar measured by a "scar-trouble scale" filled in by the patient.

Timeframe: at 18 month-follow up

Auto-evaluation of patient's scar esthetical result with a visual analog scale.

Timeframe: at 18 month-follow up