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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02246192

Enrollment

Registered

2014-09-22

Start date

2008-11-30

Completion date

2014-01-31

Last updated

2015-03-19

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

Conditions

Pilonidal Sinus

Brief summary

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

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.

Interventions

PROCEDUREsinus pilonidal excision+ PRGF

open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively

PROCEDUREsinus pilonidal excision and standard cares

sinus pilonidal excision and postoperative standard care with povidone daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

13 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
healing time(days) of pilonidal sinus wound excision	6 months

Secondary

Measure	Time frame	Description
postoperative pain	1 month	using VAS to assess postoperative pain

Other

Measure	Time frame	Description
postoperative bleeding	1 week	—
surgical site infection rate	1 month	—
sinus recurrence rate	4 years	—
quality of life	6 months	this measure is assessed asking the possibility of standing in Water closet(WC) or walking correctly.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026