Application of Platelet-rich Plasma for the Management of Pilonidal Sinus Disease: A Randomized Clinical Trial of Different Treatment Modalities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Change in Wound Healing
Study Overview
Brief 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.
Detailed Description
Pilonidal sinus disease is a health problem that has been attempted to be overcome by various treatment modalities since the first time it was described by Herbert Mayo in 1833. PS is usually diagnosed at 30 years of age, and the disease has a male predominance of 70-80%.
Common morbidities after the surgical treatment of PS are pain, loss of productive work hours and wound infections owing to long healing times. Therefore, the main goals of treatment are accelerating the healing time by decreasing pain and reducing the loss of productive work hours.
Local administration of platelet-rich plasma (PRP), which contains growth factors (Gfs), is a new method that has been reported to accelerate the healing process by 30-40% [2].
In this study, we aimed to investigate the effect of PRP on the pain score, wound-healing process and quality of life in the treatment process for PS disease.
METHOD
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in Wound Healing
Time Frame: on postoperative days 0, 2, 3, 4 and 21
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.
Secondary Outcomes
- Visual Analog Scale (VAS) score(at 24th hour, 48th hour, 96th hour, 120th hour and 3rd week)
- Short Form-36 and Nottingham Health Profile(before the surgery and in the postoperative 3rd week)
Investigators
Cihangir Akyol
Associate Proffessor
Ankara University