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Sacrococcygeal Pilonidal Sinus DiseaseHWHPSDNCT01876537

Hardware Wound Healing In Surgical Treatment Of Sacrococcygeal Pilonidal Sinus Disease

A study testing Hardware wound healing and Usual Surgery in people with Sacrococcygeal Pilonidal Sinus Disease, run by Voronezh N.N. Burdenko State Medical Academy at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

THEME RELEVANCE. Sacrococcygeal pilonidal sinus disease (SPD) is a congenital disease that's well spread and constitutes 1-2% of all surgical pathologies. In all Coloproctological pathologies, the disease composes 14-20% (G.I. Vorobjov, 2006; V.D. Fedorov, 2005; Gupta P.J. et al., 2005). Read more about this study

Who is it for?
Any age
Conditions the study is for
Sacrococcygeal Pilonidal Sinus Disease
What is being tested?
Hardware wound healing and Usual Surgery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteRussia
Study dates
Jan 2011to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinical diagnosis of Sacrococcygeal pilonidal sinus disease
  • Must be able to transfer surgery
  • Should not be allergic to antibiotics

Who cannot join

  • Low blood coagulation
  • Вiseases, reducing immunity
  • Insanity

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • Voronezh Regional Hospital #1

    Voronezh, Voronezh Regional, 394066

Other trials in Russia

About this study

Official title: Phase 1 STRENGTHENING OF THE SACROCOCCYGEAL FASCIA IN THE SURGICAL TREATMENT OF PILONIDAL SINUS DISEASE

THEME RELEVANCE. Sacrococcygeal pilonidal sinus disease (SPD) is a congenital disease that's well spread and constitutes 1-2% of all surgical pathologies. In all Coloproctological pathologies, the disease composes 14-20% (G.I. Vorobjov, 2006; V.D. Fedorov, 2005; Gupta P.J. et al., 2005). Clinical manifestations of pilonidal sinus disease mainly due to the appearance of inflammation in it.

The main approach in the complex treatment of this group of patients is to execute radical surgery. The guiding principles in it are adequate sanation and drainage of purulent focus.

Read more

Despite the fact that this disease is the subject of numerous medical journals, monographs, research works, masters and doctoral theses, frequency of unsatisfactory outcomes remains high (recurrence - from 10% to 19%, wound inflammation - 20-30%). In this case terms of stationary and out-patient treatment increase till 30-70 days (G.I. Vorobjov, 2006; B.M. Dacenko et al., 2004; Cubukcu А., 2001, Perruchoud С, 2002).

The frequency of unsatisfactory results after excision of SPD directly depends on the kind of surgery. After palliative surgery (incision and drainage of abscess) in 11.7 - 25.2% of patients occurs recurrence of the disease (McCallum I., King P.M., Bruce J., 2007;), for the open wound healing recurrence occur in 3-8% of the operated. For primary wound healing in 7,5-9,7% required re-surgery (V.K. An, 2003; A.A. Kartashev, 2011).

Sacrococcygeal pilonidal sinus disease overwhelmingly affects people, mostly young working age, and treatment failure leads to long-term temporary disability of patients.

In the last few years continue to discuss methods of one-time or multi-stage radical surgical treatment of pilonidal sinus, but to date there is no single approach to the choice of surgical treatment for this disease (V.L. Denisenko, 2008).

Success of surgical treatment of SPD depends on the development and introduction of new devices and techniques exist to produce convergence and immobilization of the wound edges, thereby obtaining its primary healing and a significant reduction of wound surface.

The high frequency of the disease and postoperative complications, as well as long-term temporary disability of patients demonstrates the relevance of the development of modern methods of radical surgery of sacrococcygeal pilonidal sinus disease (V.I. Pomazkin, 2008).

AIM OF RESEARCH. The aim of our research is to improve the results of complex radical surgical treatment of patients of sacrococcygeal pilonidal sinus disease through the development and introduction of new devices and techniques for convergence and immobilization wound edges.

TASKS OF RESEARCH.

  1. To conduct a comparative analysis the most common surgical treatment of SPD in the frequency of complications in the intra- and postoperative periods.
  2. To develop a device for convergence and immobilization wound edges in patients with SPD.
  3. To analyze the effectiveness of the developed techniques and devices in comparison with traditional surgical treatment.
  4. To make practical recommendations on the options and methods of using the developed methods and devices.

NOVELTY OF RESEARCH. For the first time, based on the design and creation of an approximation-immobilization device (RU Patent № 112020, Bull. № 1, 01.10.2012) will be improved the surgical treatment of patients with this pathology, clinical and anatomical study of the proposed device for different configurations of gluteal-sacrococcygeal region, as well as the analysis and justification of the basic parameters of wound (length, depth and width of the wound, the number of stitches, the complication rate , the area of the wound).

Developed a method of closure of the wound defect after radical excision of pilonidal sinus by Krivonosov-Brezhnev (RU Patent № 2,464,943, Bull. № 30 from 10.27.12.), that significantly reduces the risk of postoperative complications in patients with acute inflammation of the SPD.

For the first time an analysis of postoperative period in patients operated with the proposed methods compared with traditional methods of surgery was performed.

POSSIBLE APPLICATION AREAS. Results of the research designed for use in the treatment process of coloproctological departments at all levels, as well as the learning process of medical schools.

EXPECTED EFFECTIVENESS.

  1. Scientific and technical effect: developed new techniques and devices for convergence and immobilization wound edges used for the treatment patients with SPD.
  2. Medical and social effects: the introduction into clinical practice of the developed techniques and devices will improve the results of surgical treatment of patients with SPD by rigid fixation of wound edges, by reducing the time of postoperative wound healing, by decreasing the risk of complications in the early postoperative period.
Being tested
Hardware wound healing, Usual Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hardware wound healingDevice

  • Usual SurgeryDevice

Study groups in NCT01876537
Study groupRoleWhat they receive
Usual surgeryActive comparatorNot described
Receives: Device: Usual Surgery
Hardware wound healingActive comparatorNot described
Receives: Device: Hardware wound healing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. primary wound closure

    Measured: up to 10-15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2013 (estimated)
  2. Study startJan 2011
  3. Primary completionJun 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01876537
Sponsor's protocol ID
ZHKB-2015
Acronym
HWHPSD
Status last verified
Nov 2020
First submitted
10 Jun 2013
Last updated
9 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hardware wound healing and Usual Surgery in people with Sacrococcygeal Pilonidal Sinus Disease, run by Voronezh N.N. Burdenko State Medical Academy at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary wound closure (time frame: up to 10-15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.

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