Application of Platelet-rich Plasma in Pilonidal Sinus Disease

NCT04697082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-01-06

No results posted yet for this study

Summary

Pilonidal sinus disease is a common health-care problem, and surgical excision is the standard treatment modality. Controversy still exists regarding the best surgical technique for treating pilonidal disease in terms of minimizing disease recurrence and patient discomfort. In this study, the investigators compared the impact of autologous platelet-rich plasma (PRP) with that of minimally invasive techniques on pain reduction, return to daily activities, quality of life, and duration of wound healing after open excision and secondary closure.

Conditions

  • Pilonidal Sinus
  • Pilonidal Disease
  • Wound Heal
  • Quality of Life
  • Pain

Interventions

PROCEDURE

Open surgery

Each patient entered the operating room, and after the administration of general anaesthesia, the patient was placed in the prone position. Then, the buttocks were stretched to the lateral sides using adhesive bands to remove the disease area. The sacrococcygeal region was cleaned and disinfected with 10% povidone iodine. After covering the area around the region, the sinus tract was examined by using a thin-steel cane. The length and wealth of the cavity were noted. Then, the sinus tract was removed. The depth of the cavity was noted. Then, 50 cc of 0.9% saline solution (SS) was taken into a syringe and applied to the cavity until it filled the whole space, allowing the cavity volume to be measured accurately. The measurement was performed by subtracting the remaining saline-solution volume in the syringe from the whole syringe volume, which was 50 cc.

PROCEDURE

Minimal invasive surgery

In the operating room, after the patient was placed in the prone position, the region was removed by stretching the buttocks with adhesive bands and cleaning the area with 10% povidone iodine. The largest pit was excised, and hairs in the cavity were removed with forceps. Then, the whole cavity was curetted meticulously and irrigated with SS. After haemostasis, the cavity volume was measured

OTHER

Platelet rich plasma administration

Platelet rich plasma (PRP) was administered by filling the whole space from the lateral side of the cavity. After the first implementation of PRP, the second one was applied at 48 hours. Until that time, the dressing was not uncovered. PRP was applied on the 3rd, 4th and 5th days postoperatively.

Sponsors & Collaborators

  • Cihangir Akyol

    lead OTHER

Principal Investigators

  • Can Y Boztug, MD · Ankara University School of Medicine Departmernt of General Surgery

  • Cihangir Akyol, MD · Ankara University School of Medicine Departmernt of General Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-01-01
Completion
2019-07-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697082 on ClinicalTrials.gov