Pain Clinical Trial
Official title:
Application of Platelet-rich Plasma for the Management of Pilonidal Sinus Disease: A Randomized Clinical Trial of Different Treatment Modalities
Verified date | January 2021 |
Source | Ankara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | July 1, 2019 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - chronic pilonial sinus disease - patients who had undergone abscess drainage and remained diseased after 8-10 weeks of drainage Exclusion Criteria: - patients with acute abscess - patients with anemia - patients that use immunosuppressive drugs - patients with haematological malignancy - patients with bleeding disorder - patients with recurrent pilonida sinus disease |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University School of Medicine Department of General Surgery | Ankara |
Lead Sponsor | Collaborator |
---|---|
Cihangir Akyol |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Wound Healing | Wound healing rate was evaluated as recovery time per the cavity volume (day/cc). This showed the time required for each 1 cc volume of the cavity to be filled on a daily basis. After open or minimally invasive surgery, the volume of the cavity was measured with saline solution. The cavity was filled with saline and the volume of the cavity was determined by calculating how much fluid it took. The measurements were performed on postoperative days 0, 2, 3, 4 and 21. Therefore recovery time per the cavity volume was calculated according to the differences between the measurements. | on postoperative days 0, 2, 3, 4 and 21 | |
Secondary | Visual Analog Scale (VAS) score | We used a visual analogue scale (VAS) to evaluate the pain score. The VAS score can range from 0 to 10. The higher the score, the higher sensation of pain. The VAS was applied five times after surgery: at 24 hours, 48 hours, 96 hours, 120 hours and 3 weeks. Patients were routinely prescribed "dexketoprofen trometamol" and recommended to take it no more than 2 times a day. How many tablets the patients used after the operation was recorded. | at 24th hour, 48th hour, 96th hour, 120th hour and 3rd week | |
Secondary | Short Form-36 and Nottingham Health Profile | Short Form-36 (SF-36) and Nottingham Health Profile (NHP) questionnaires were applied to evaluate the quality of life before the surgery and three weeks after.
The SF-36 consists of eight scaled scoresand each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The NHP consists of two parts. The highest score in any section is 100 The higher the score, the greater the number and severity of problems We assessed the general health, limitations or activities, physical health problems, emotional health problems, social activity, pain, energy and emotions of the patients with the SF-36 questionnaire. Additionally, we evaluated the pain, energy level, emotional reaction, sleep, social isolation, and physical abilities of patients with the NHP questionnaire. |
before the surgery and in the postoperative 3rd week |
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