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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

Comparing the efficacy of amniotic membrane allograft with conventional dressing methods on the duration of treatment of pilonidal sinus patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221008056113N1
Enrollment
30
Registered
2023-07-13
Start date
2023-07-23
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal sinus. Pilonidal cyst and sinus without abscess

Interventions

Intervention group, in addition to the usual care of the wound, amnion-chorion dry sheets are used for dressing, and this product is provided under the brand name Life Cell from Bazar Teb Company. For

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsa Yousefi

Mashhad University of Medical Sciences

yousefia952@mums.ac.ir+98 51 3840 9642

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026