Clinical Trials Logo

Cicatrix clinical trials

View clinical trials related to Cicatrix.

Filter by:

NCT ID: NCT05449457 Active, not recruiting - Scarring Clinical Trials

Aesthetic Outcome of Layered Closure vs. Layered Closure Followed by 2-Octyl Cyanoacrylate

Start date: October 6, 2022
Phase: N/A
Study type: Interventional

Following skin surgeries on the head and neck, several surgeons use a type of surgical glue (such as Dermabond) as a final layer on the top of wound. This glue is thought to seal the wound. Up until this point, there is limited data about the exact advantages or disadvantages of using this glue. We wish to determine if there is a difference in the cosmetic outcome of the scar when the glue is applied compared to when the glue is not applied. In addition, we want to determine if patients prefer to care for a wound with or without the glue.

NCT ID: NCT05439733 Recruiting - Scarred Uterus Clinical Trials

Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study

CICAMODA
Start date: August 2, 2022
Phase:
Study type: Observational

In women with one previous caesarean, the choice of mode of delivery is determined by a shared decision-making process between the women and the obstetrician, with the two options being a trial of labour after caesarean (TOLAC) or an elective repeat caesarean delivery (ERCD). To date, the scientific literature has reported of higher perinatal morbidity-mortality with TOLAC, although with low absolute risks and discordant results about maternal morbidity-mortality. These studies suffer from limitations, as they include women with more than one previous caesarean or with high rates of failed TOLAC, which are two risk factors for uterine rupture, and the definition of planned versus effective mode of delivery is not precise in most studies. However, scientific societies recommend that most women with one previous caesarean should be offered TOLAC because of the low absolute perinatal risk of this option and the high maternal and perinatal risk associated with an ERCD in the short- and long-term. Conversely, the investigators hypothesise that TOLAC would be not inferior to ERCD in women with one previous caesarean in terms of perinatal morbidity-mortality.

NCT ID: NCT05412745 Completed - Keloid Clinical Trials

Class I Medical Device on Post-surgical Scars

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

To compare the effect of a class I pullulan based medical device containing Allium cepa & HA versus a class I medical device silicone gel on new post-surgical wounds

NCT ID: NCT05386732 Completed - Acne Scarring Clinical Trials

Safety and Efficacy of the 4MD Micro Needling Device in the Treatment of Acne Scars

Start date: June 19, 2020
Phase:
Study type: Observational

The objective of this post market clinical follow-up study is to assess the safety and effectiveness of the 4MD microneedling device in reducing scarring of atrophic acne scars. The Primary endpoint was to show a reduction in acne scarring in accordance with the Acne Scar Assessment Scale as used by Skinpen (Bellus Medical (DEN160029)). Goodman and Baron and Jacob acne scar assessment and classification will also be utilized Safety endpoint: incidence of adverse events and side effects

NCT ID: NCT05385159 Recruiting - Scarred Vocal Folds Clinical Trials

INNOVATIVE TREATMENT OF SCARRED VOCAL FOLDS BY LOCAL INJECTION OF AUTOLOGOUS ADIPOSE-DERIVED STROMAL VASCULAR FRACTION: EFFICACY VERSUS PLACEBO

CELLCORDES2
Start date: September 22, 2022
Phase: Phase 2
Study type: Interventional

Vocal Folds scarring (whether congenitally or following phonosurgery) can result in a range of symptoms depending on severity and extent, such as hoarseness, breathy voice, increased effort to speak, and voice fatigue. The inability to phonate normally causes both physical and psychological disability, especially for professional communicators (teachers, tradesmen, singers, etc.). There are several therapies currently available but these are often disappointing, as the great complexity of vocal fold microstructure hinders the development of effective therapy. Thus, identification of innovative strategies able to improve vibrational mechanical properties of vocal folds remains an important clinical challenge. Autologous Adipose-Derived Stromal Vascular Fraction (ADSVF) is recognized as an easily accessible source of cells displaying angiogenic, anti-inflammatory, immunomodulatory and regenerative properties. Recent experimental and clinical reports also supported the anti-fibrotic potential of ADVSF, mainly attributed to the mesenchymal stem/stromal cell subset. Safety in humans has already been confirmed in several studies, including our previous clinical trial (ClinicalTrials.gov NCT0262246; EudraCT number: 2015-000238-31). The main objective of this phase I/II trial was to measure for the first time the safety and tolerability of autologous ADSVF local injections in patients with scarred vocal folds. No severe adverse events occurred: only some minor adverse events were reported. Moreover, Voice Handicap Index was improved in all patients with a mean improvement from baseline of 40.1/120 and seven patients were considered as responders, defined as an improvement ≥ 18 points. Based on these observations, we hypothesized that the injection of autologous ADSVF could reduce the process of fibrosis, improve vibration and then dysphonia and quality of life in patients with scarred vocal folds. In the absence of a reference treatment, the effectiveness of the ADSVF will be compared to a placebo: the local injection of excipients solution. This study will test efficacy of the autologous ADSVF to treat vocal folds scarring. It is a randomized, double-blind, phase II clinical trial conducted according to a 2-treatment parallel design, with medico-surgical and scientific collaboration. Recruitment and follow-up of patients will be done in 4 university hospitals by the respective ENT teams (Marseille, Toulouse, Nice and Montpellier): 36 patients will be recruited and treated on a 24 months period. At inclusion, 36 patients will be randomized (1:1 ratio) into two groups: ADSVF group and placebo group. Adipose tissue removal, ADSVF production and injection of ADSVF or placebo will be done on the same day during a short hospital stay. Patients will be followed and evaluated at 1 and 6 months with self-evaluation (Voice Handicap Index and a 10 points scale), video-laryngo-stroboscopic examination, vocal assessment with perceptive, acoustic and aerodynamic parameters and evaluation of adverse events. At the end of this 6-month follow-up (primary endpoint), patients of each group having tolerated the first injection well but in therapeutic failure (improvement of VHI <18 as described by Jacobson in 1997 or improvement of VHI ≥ 18 but not normal which means > 20 according to Woisard, 2004) will be offered an injection of thawed and washed ADSVF. Patients will continue to be followed in open-label on the same endpoints.

NCT ID: NCT05377723 Recruiting - Clinical trials for Breast Reconstruction

Abdominal Scar Improvement in Microsurgical Breast Reconstruction

Start date: October 31, 2022
Phase: N/A
Study type: Interventional

Microsurgical breast reconstruction is most commonly performed with free abdominal flaps, which leave a long transverse lower abdominal scar. Due to tension across the incision, these scars frequently widen and hypertrophy. Hence, modalities that can reduce this tendency, thus, improving scar appearance are desirable. Here, we wish to investigate the impact of the Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is novel in that it is the first RCT investigating the effect of the embrace device on scar appearance in the context of microsurgical breast reconstruction.

NCT ID: NCT05355181 Completed - Back Pain Clinical Trials

Scar Mobilization Techniques vs Core Stability Exercises on Scar Tissue and Lumbopelvic Pain

Start date: April 20, 2022
Phase: N/A
Study type: Interventional

The study will be a Randomized clinical trial to check the effects of scar mobilization techniques with and without core stabilization exercises on scar tissue mobility and lumbopelvic pain in females after a cesarean section suffering from back pain and restricted scar mobility. Duration of study will 6 months, convenient sampling technique used, subject following eligibility criteria from Rafiqa Medical Centre, Sargodha and Fatima Hospital, Sargodha, will randomly be allocated in two groups via lottery method, baseline assessment will be done, Group A participants will be given baseline treatment along with scar mobilization and core stabilization exercises, Group B participants will be given baseline treatment along with scar mobilization for 3 weeks. On the 5th and 9th day, the post-intervention assessment will be done via, Manual Scar mobility testing, Vancouver Scar Scale, Numeric Pain Rating Scale, and Oswestry Disability Index. 3 sessions per week will be given.

NCT ID: NCT05345600 Recruiting - Pain Clinical Trials

MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery

MILTADoIP
Start date: March 15, 2022
Phase: N/A
Study type: Interventional

The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic. The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars. This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.

NCT ID: NCT05271708 Completed - Scar Clinical Trials

Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery

Start date: January 5, 2022
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the efficacy of the Fespixon cream for prevention and/or appearance reduction of different types of linear scars during the 12-week treatment phase, which is assessed by the blinded independent evaluator.

NCT ID: NCT05239351 Completed - Lipodystrophy Clinical Trials

Evaluating Performance and Safety of the Medical Device Jalucomplex in the Treatment of Facial and Neck Tissue Defects

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

The Research Question of the present study is the following: in a population of men and women presenting facial and neck dermal tissue defects (scars, hypertrophic scars, depressed plaques, and lipodystrophy defects) will linear hyaluronic acid (Jalucomplex®) significantly decrease and / or improve their appearance, results observed after 4 and 8 weeks?