Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision

Study Overview
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Brief Summary
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The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the healing process of the wound, when compared with the usual technique of daily local healing. The investigators propose the objective of evaluating the efficacy of intra- and postoperative application of plasma rich in growth factors, to reduce healing time and complications, arising from its removal, compared to the standard surgical treatment.

Detailed Description
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prospective randomized control trial, comparing PRGF application vs daily local care(betadine +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and infiltrated in the pilonidal wound every week. this treatment is compared with betadine and saline wound care in terms of wound healing time, pospoperative pain and other complications. this study try to keeps the advantages of using open technique for pilonidal desease( low recurrence rate and surgical site infections) and improving the disadvantages (high wound healing time and postperative pain with wore quality of life) when it´s compared with direct closure or flap techniques.

Official Title
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Application of PRGF (Plasma Rich in Growth Factors) to Reduce the Healing Time After Pilonidal Sinus Excision. A Randomized 5-years Prospective Controlled Trial.

Conditions
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Pilonidal Sinus

Intervention / Treatment
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* Procedure: sinus pilonidal excision+ PRGF
* Procedure: sinus pilonidal excision and standard cares


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients among 13 and 65 years old Possibility of observation during the follow-up period Patients who have read and signed informed consent Exclusion Criteria: Abscessed pilonidal sinus Recurrent pilonidal sinus Patients treated with immunosuppressive drugs or anticoagulants

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>sinus pilonidal excision and standard cares | Procedure: sinus pilonidal excision and standard cares<br>* sinus pilonidal excision and postoperative standard care with povidone daily<br>|
| Experimental: PRGF group<br>sinus pilonidal excision+ PRGF | Procedure: sinus pilonidal excision+ PRGF<br>* open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing time(days) of pilonidal sinus wound excision |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | using VAS to assess postoperative pain | 1 month |