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Evaluation of the effect of amniotic membrane allograft on duration and costs of treatment in pilonidal disease compared with conventional methods

Phase 3
Recruiting
Conditions
Pilonidal sinus.
Pilonidal cyst and sinus without abscess
L05.9
Registration Number
IRCT20221008056113N1
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Patients over 18 years old with the first manifestation of pilonidal sinus disease one week after surgery
Surgical wounds with a size of 4 x 4 cm and larger without infection

Exclusion Criteria

Pilonidal sinus with abscess formation
Underlying chronic diseases that disrupt wound healing, such as diabetes and connective tissue diseases.
Glucocorticoid consumption during the study period

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The time required for wound healing until the complete formation of the epithelium. Timepoint: After the initial visit one week after surgery, patients are examined two weeks later (i.e. the third week after surgery) and then weekly for 6 to 8 weeks (depending on the time required for wound healing). Method of measurement: Examination of wounds is performed by a single experienced nurse and familiar with the wound healing process who will receive the necessary training.
Secondary Outcome Measures
NameTimeMethod
Total cost for wound care, including the cost of purchasing dressings, antibiotics, and painkillers, as well as the cost of weekly visits. Timepoint: At the end of the study. Method of measurement: All these costs are calculated regardless of insurance, and the patients will be asked at each visit and compared in two groups at the end of the complete recovery process.
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