Wounds and Injuries

All Conditions

Neoplasms

Symptoms and General Pathology

Pilonidal Sinus

Cysts

The wound will be cleaned (irrigation with Physiological Serum), the cavity and the perilesional area will be dried with gauze. A skin protection spray will be applied to avoid irritation of the skin around the wound due to the adhesive of the dressing. The cavity will be filled with a sponge. When the depth of the wound is less than 1.5 cm, it will not be necessary to fill the defect. The appropriate dressing will be applied to the size of the incision, reinforcing the edges, and it will be connected to the TPN device, ensuring correct functionality.

Negative pressure therapy

The wound will be cleaned with physiological serum irrigation, the cavity will be dried with gauzes and filled with a dressing made of cellulose and silver. A skin protection spray will be applied to avoid irritation of the skin around the wound due to the adhesive of the dressing.

Conventional wound care

Ana Gálvez Saldaña

Domenico Fraccalvieri

Sebastiano Biondo, MD, PhD

Sebastiano Biondo, MD

Pilonidal Sinus PS is a prevalent disease in young patients. There is currently no consensus on the surgical treatment of choice. Each method is associated with different advantages and disadvantages, as well as different recurrence rates. The ideal treatment should reduce morbidity, be associated with a short hospital stay (outpatient surgery), promote rapid healing, early return to work, and have a low recurrence rate. To date, no technique meets all these criteria. However, the NPT could meet them. The use of NPT in PS could decrease healing time, achieving an early return to work. In addition, it would avoid the need for daily dressings, which would mean lower hospital costs. However, the location of the wound (sacrum) and its proximity to the anal margin mean that its use cannot be generalized.

Although two retrospective series have recently reported good results with the use of NPT in PS, a prospective, randomized study is needed to compare healing time, recurrence rates, hospital costs, and assess quality of life for determine if this could be the treatment of choice.

Although NPT is commonly used in clinical practice (being useful in closing complex wounds, with devitalized tissues, burns and wounds with exposed tendons), to date there is not enough evidence to support its use after flattening the PS and it is for this reason that we conducted this study.

In this project there is a total absence of commercial interest in the proposal. No project related to the proposed one is currently being carried out.

The study population will be made up of all patients with PS admitted to the General and Digestive Surgery service of the Hospital Universitari de Bellvitge from the start of the trial until the end of recruitment, and who meet the inclusion criteria.

Once the patients belonging to the population of interest have been identified, they will propose to participate in the clinical trial, providing complete information, as well as an information sheet with the details of the study. If you agree, the informed consent document will be provided for your signature and randomization will proceed.

Bitter et al. observed in a prospective study that the use of NTP did not reduce healing time compared to conventional closure 84 days (34-349) vs 93 days (43-264); p=0.44. However, the duration of NPT application of only 2 weeks might have been too short to see an adequate effect. Also, the small sample size could have influenced the results. On the other hand, recent publications on the use of TPN in the treatment of pilonidal sinus have shown a significant reduction in healing time (28 days) with minimal complications and adequate patient satisfaction. Taking into account the scarce evidence of the studies cited, we have decided to adopt a conservative criterion, assuming a smaller difference in time to healing between the two treatments (35 days).

To calculate the sample size, the time variable has been transformed into a logarithm. Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 94 patients, 47 subjects in the control group and 47 in the experimental group, are needed to detect a difference of 0.77. A common standard deviation of 1.26 is assumed. A rate of loss to follow-up of 10% has been estimated.

Randomization 1:1 will be performed using a statistical program at the baseline visit in outpatient clinics 48 hours after surgery, after assessing the dimensions of the wound, checking whether the participant meets the inclusion/exclusion criteria and has signed the informed consent.

For the purposes of the study and in order not to influence the type of surgery performed on patients with PS, only those patients who have undergone a flattening will be included. The 1st cure will be performed 24 hours later in the area outpatient clinic and will consist of removing the dressing, washing with physiological serum and placing a dry dressing.

48 hours after surgery, patients will be evaluated in outpatient clinics at our hospital. The dressing will be removed from the wound and after washing with serum, it will be checked if the patient meets the inclusion criteria. If you meet them, you will be offered to participate in the study and once you have signed the informed consent, randomization will proceed.

The patients will be monitored in person in outpatient clinics (CEX) by two members of the research team, made up of a nurse specialized in cures and a doctor specialized in surgery.

During the follow-up visits, a conventional dressing will be performed or the negative pressure system will be changed. Symptomatology and quality of life data will be collected through validated surveys.

PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.

RANDOMIZED COMPARATIVE CLINICAL STUDY BETWEEN TWO TREATMENT STRATEGIES IN PATIENTS WITH PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.

Time in days from surgery to complete epithelialization of the wound, assessed by the dressing nurse and surgeon.

Defined as wound volume measured in milliliters. In addition, the measurements of width, length and depth in cm will be collected.

Evaluated with the visual analog pain scale ranging from 0 to 10, where 0 represents no pain and 10 represents intolerable pain. It will be assessed weekly

Time in days from surgery to incorporation into daily activities as reported by the patients in the weekly evaluation

Evaluated by applying the SF-36 questionnaire in both groups at 15 days, 30 days, and monthly until healing. A total score will be calculated in each of the 8 sections and converted to a scale from 0 to 100, with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability.

Reported by the patient on a scale of 0 to 10, where 0 corresponds to "totally unsatisfactory" and 10 corresponds to "totally satisfactory". The score obtained at the end of healing will be recorded. It will be done when healing is complete.

Disease recurrence will be assessed 1 year after surgery.

Hospital Universitari de Bellvitge

Sebastiano Biondo

PhD, MD

Blood and Lymph Conditions

Skin and Connective Tissue Diseases

Lymphedema

Breast Neoplasms

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

This group includes 34 patients who will receive 30 min Endermologie 3 times per week in addition to their physical therapy program (active range of motion and elevation); hygiene and skin care for 6 weeks.

This group includes34 patients who will receive 30min negative pressure therapy 3 times per week in addition to their physical therapy program (active range of motion and elevation); hygiene and skin care for 6 weeks

Group A will receive -18 sessions by Endermologie system used to decrease postmastectomy lymphedema for group (A), three sessions per week for six weeks.

Each session was 30 minutes at the posterior thorax, upper arm, forearm and the hand.

-In addition to physical therapy program (active range of motion and elevation); hygiene and skin care

Endermologie

Group B will receive negative pressure therapy with

* Pressure: 20-250 mmHg.
* Total treatment period: 6weeks
* A number of sessions: 3sessions/ week. Time of application : 30 min
* In addition to physical therapy program (active range of motion and elevation); hygiene and skin care

Rayda M Mohamed

Statement of the problem:

The problem will be stated in a questionary form:

"Which will be more effective endermologie or negative pressure therapy in reducing limb circumference and volume in postmastectomy lymphedema?".

Hypothesis:

It will be hypothesized that:

There is no significant difference between endermologie and negative pressure therapy in reducing circumference and limb volume in post mastectomy lymphedema.

Subject:

Sixty- eight women treated for unilateral breast cancer with secondary upper limb lymphedema post mastectomy will participate in this study. Their ages will be ranged from 40 to 60 years, they will be free from any other diseases that will affect or influence the results and the participants will be selected from National Cancer Institute and randomly distributed into two equal groups in number.

Study design:

In this study the patients will be randomly assigned into two groups equal in number (34 patients for each group).

Inclusion Criteria:

The subject selection will be according to the following criteria:

* Only females will participate in the study.
* Patients' age will be ranged between 40-60 years.
* All patients will suffer from post mastectomy lymph-edema.
* All patients have a modified radical mastectomy.
* All patients will suffer from grade II lymph edema without skin changes one year post mastectomy.
* All patients are right-dominant hand.
* All patients enrolled to the study have their informed consent.

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

* primary lymph-edema.
* Diabetes mellitus.
* Pregnancy.
* Recurrent cancer.
* Current or recent cellulitis.
* Current metastases.
* Venous thrombosis.
* Photosensitivity.
* Phlebitis in development stage.
* Infection.
* Receiving anti-coagulant treatment.

Equipment:

The study equipment's will be divided into measurement and therapeutic equipment and tools:

1: Measurement equipment

1(a):Limb volume measurement:

This will be performed by measuring the circumference of each segment of the limb between two consecutive circumferences as a truncated zone. The volume of the segment was calculated as:

V=h (c12+c1c2+c22 )/12π, where V is the volume of the segment, c1 and c2 are the circumferences at the ends of the segment, and h is the distance between them.

Measurement of limb volume measurement will be conducted pre-treatment and after treatment course (6 weeks).

1. (b): Measuring Disability of the arm, shoulder and hand by: .Quick DASH questionnaire (Disability of the arm, shoulder, and hand).

   * The Quick- DASH has five response options for each item from 0=no difficulty to perform or no symptoms to 5=unable to do.
   * Quick DASH scale will be conducted pre-treatment and after treatment course (6 weeks).
2. Therapeutic equipment :

2. a. Endermologie: endermologie therapy will be three sessions per week for six weeks (total 18 sessions).

The study group will receive 18 sessions by Endermologie system ( used to decrease postmastectomy lymphedema for group (A), three sessions per week for six weeks.

Each session was 30 minutes at the posterior thorax, upper arm, forearm and the hand.

2.b. Negative pressure therapy:

* Pressure: 20-250 mm Hg.
* Total treatment period: six weeks.
* A number of sessions: 3 sessions/ week. Time of application : 30 min

Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema

Measuring Disability of the arm, shoulder and hand will be carried out by using Quick-DASH questionnaire

Limb volume measurement will be carried out by by measuring the circumference of each segment of the limb between two consecutive circumferences as a truncated zone. The volume of the segment was calculated as:

V=h (c1+c1c2+c2 )/12π

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.	NCT05474911	Pilonidal Sinus Wound Heal	Negative pressu... Conventional wo...	17 Years -	Hospital Universitari de Bellvitge
Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema	NCT05761353	Mastectomy; Lym...	Endermologie Negative pressu...	40 Years - 60 Years	Cairo University
PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.	NCT05474911	Pilonidal Sinus Wound Heal	Negative pressu... Conventional wo...	17 Years -	Hospital Universitari de Bellvitge

Spots Global Cancer Trial Database for negative pressure therapy