EUCTR2009-012703-25-SE进行中（未招募）不适用
A prospective double-blind, randomised concept study of PXL01 versus placebo in flexor tendon surgery. - PHSU02
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pergamum AB
- 入组人数
- 138
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The following entry criteria apply:
- •1. Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of the flexor digitorium superficialis (FDS) and possible to rejoin with tendon suture
- •2. Open flexor tendon injury sutured within 14 days after trauma
- •3. 12-75 years of age
- •4. Signed informed consent prior to any study related procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •If one or more of the following criteria are fulfilled, the patient should not be included in the study:
- •1. Treatment with any investigational product within 4 weeks of study entry
- •2. Patients previously included in the study
- •3. Thumbs with complete or partial division of flexor pollicis longus (FPL)
- •4. Concomitant fracture(s) requiring immobilisation
- •5. Injuries with associated soft tissue loss
- •6. Severe crush injury
- •7. Palmar plate injury requiring immobilisation
- •8. Devascularisation/requirement of vascular repair
- •9. Joint injuries
- •10. Bilateral injuries
- •11. Previous flexor tendon surgery in the digit, which is to be treated wih IMP
- •12. Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury
- •13. Compliance with mobilisation protocol not expected
- •14. Alcohol or drug abuse
- •15. Severe intercurrent illness, which in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient’s ability to take part in the study
- •16. Pregnant or lactating females
- •17. Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner during the first two weeks post-surgery. A condom alone is not considered an acceptable method for birth control, not even together with spermicide.
- •18. Known allergy to any component of the study product or placebo
- •19. Patients suffering from:
- •- Diabetes Mellitus patients where significant diabetic complications may delay healing according to the investigator’s judgement
- •- Rheumatoid arthritis
- •20. Or patients treated with:
- •- Systemic steroids within one month
- •- Immunosuppressive drugs within three months
- •- Daily use of NSAIDs within one week or occasional use within 8 hours
研究者
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A prospective double-blind, randomised concept study of PXL01 versus placebo in flexor tendon surgery. - PHSU02Patients with flexor tendon injuries in zone I or II that are admitted to the respective site will be considered for inclusion and informed about the study.MedDRA version: 15.0Level: PTClassification code 10043248Term: Tendon ruptureSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsEUCTR2009-012703-25-DKPergamum AB138
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