Skip to main content
OpenTrials
Completed

NCT Number: NCT02246192

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sinus pilonidal excision+ PRGF

Procedure

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

sinus pilonidal excision and standard cares

Procedure

sinus pilonidal excision and postoperative standard care with povidone daily

Primary outcomes

  1. healing time(days) of pilonidal sinus wound excision

    Time frame: 6 months

Secondary outcomes

  1. postoperative pain

    Time frame: 1 month

    using VAS to assess postoperative pain

Other outcomes

  1. postoperative bleeding

    Time frame: 1 week

  2. surgical site infection rate

    Time frame: 1 month

  3. sinus recurrence rate

    Time frame: 4 years

  4. quality of life

    Time frame: 6 months

    this measure is assessed asking the possibility of standing in Water closet(WC) or walking correctly.

Sponsors and collaborators

Lead sponsor

Hospital Quiron Sagrado Corazon

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2014
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.