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

March 18, 2015 updated by: Juan Bellido Luque.MD, Hospital Quiron Sagrado Corazon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Quiron Sagrado Corazon

Investigators

  • Principal Investigator: Juan Bellido Luque, Quirón Sagrado Corazón Hospital, Seville, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sinusprgf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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