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Cicatrix clinical trials

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NCT ID: NCT05555602 Recruiting - Cryotherapy Effect Clinical Trials

Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

To investigate the effect of 10,600 nm CO2 laser combined with Zimmer Cryo 6 forced cold air device on the comfort and efficacy of patients with burn scars or post-operative linear scars, and to provide a safer, more effective and more satisfactory program for clinical treatment of burn scars or post-operative linear scars.

NCT ID: NCT05478551 Active, not recruiting - Scar Clinical Trials

Randomized Controlled Trial Examining the Efficacy of Botulinum Toxin in Biopsy Scar Minimization

Start date: June 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The proposed study seeks to evaluate the scar reduction capacity of BTA on excision/biopsy wounds compared to the control (normal saline) in a double-blinded randomized control trial. It will expand upon previous studies that have already demonstrated the safety and good tolerance profile of BTA. We will be conducting a split-scar study/study involving two biopsy sites in a singular patient, allowing them to serve as their own control. In keeping with the results from previously conducted studies, we hypothesize that the wounds treated with BTA will have significantly less evidence of scar formation than those sites treated with normal saline.

NCT ID: NCT05470322 Not yet recruiting - Clinical trials for Hidradenitis Suppurativa

Efficacy and Tolerability of a Fractional Ablative Erbium Laser for Axillary Scarring for Hidradenitis Suppurativa Patients

Start date: July 2024
Phase: N/A
Study type: Interventional

Single center, open-label, baseline-controlled study evaluating the use of a Sciton fractionated ablative laser in the treatment of Hidradenitis Suppurativa (HS) scarring.

NCT ID: NCT05460611 Recruiting - Clinical trials for Androgenetic Alopecia

1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia

Start date: December 7, 2023
Phase: N/A
Study type: Interventional

Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.

NCT ID: NCT05449457 Completed - 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.