Clinical Research Directory

Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care

A prospective, randomized clinical study with a blinded evaluator to compare a post-surgical abdominal scar care protocol using Ozoaqua products versus standard care in patients undergoing open abdominal surgery. The primary objective is to assess whether the use of Ozoaqua, initiated in the immediate postoperative period according to wound evolution, improves abdominal scar quality at 3 months compared with usual care. The proposed design is an initial single-center study at the Clínica Universidad de Navarra, with 1:1 random allocation to two parallel arms: an intervention group receiving standard care plus Ozoaqua ozonated soap and oil, and a control group receiving standard care only. The primary scar assessment will be performed by a blinded evaluator, while treatment will be open-label due to the nature of the topical intervention. The target population consists of adult patients undergoing scheduled open abdominal surgery, with primary wound closure and an assessable linear abdominal scar. Follow-up will be integrated into routine clinical care, including an in-hospital phase during the first postoperative days and outpatient visits at approximately 2 weeks, 1 month and 3 months, with the latter being the main study visit. The primary endpoint will be scar quality at 3 months, assessed using the POSAS scale, particularly the blinded observer score. Secondary endpoints will include the patient POSAS score, scar evolution, wound complications, pain, pruritus, satisfaction, cutaneous adverse events, rescue treatments and adherence.

Tape Application Protocol for Enhanced Scars

What is the purpose of this study? The Investigators want to find out whether applying Micropore surgical tape to the medial half of the mastectomy scar for 3 months helps improve its appearance after 12 months, compared to no intervention. Why is this study important? Scars can cause discomfort and affect how people feel about their bodies. The tape is thought to reduce stress on healing skin and possibly lead to a better-looking scar. But The Investigators need strong evidence to know whether it really helps. How will the study be done? This is a randomized, observer-blinded trial. Women having mastectomy are randomly assigned to either receive the tape on half their scar or receive no tape. A plastic surgeon and a breast surgeon-who do not know which side had tape-will evaluate wounds using photos after 3 and 12 months. Patients will also rate their scars using a questionnaire (POSAS), giving their personal view on color, thickness, stiffness, and symptoms like itch or pain. What else are The Investigators looking at? The Investigators will examine whether the treated half of the scar looks better than the untreated half within the same woman-this helps control for individual skin differences. The Investigators will also compare treated versus untreated areas across different women to see if there is a consistent benefit. If the untaped half of scars looks different from control scars, this may suggest differences between the groups that affect results. What will this study reveal? It will show whether using the tape improves cosmetic outcomes after mastectomy, and whether patients and clinicians agree on how scars heal. The findings may guide better post-surgery care to reduce scars and improve confidence and quality of life.