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.
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.
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.
- To conduct a comparative analysis the most common surgical treatment of SPD in the frequency of complications in the intra- and postoperative periods.
- To develop a device for convergence and immobilization wound edges in patients with SPD.
- To analyze the effectiveness of the developed techniques and devices in comparison with traditional surgical treatment.
- 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.
- Scientific and technical effect: developed new techniques and devices for convergence and immobilization wound edges used for the treatment patients with SPD.
- 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.
- Conditions
- Sacrococcygeal Pilonidal Sinus Disease
- 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 group | Role | What they receive |
|---|---|---|
| Usual surgery | Active comparator | Not described Receives: Device: Usual Surgery |
| Hardware wound healing | Active comparator | Not described Receives: Device: Hardware wound healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted12 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacrococcygeal Pilonidal Sinus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Voronezh N.N. Burdenko State Medical Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brezhnev Stanislav Gennadievich, Voronezh N.N. Burdenko State Medical Academy
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 STRENGTHENING OF THE SACROCOCCYGEAL FASCIA IN THE SURGICAL TREATMENT OF PILONIDAL SINUS DISEASE
- ClinicalTrials.gov ID
- NCT01876537
- Acronym / sponsor ID
- HWHPSD / ZHKB-2015
- Conditions
- Sacrococcygeal Pilonidal Sinus Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Voronezh N.N. Burdenko State Medical AcademyUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- To conduct a comparative analysis the most common surgical treatment of SPD in the frequency of complications in the intra- and postoperative periods.
- To develop a device for convergence and immobilization wound edges in patients with SPD.
- To analyze the effectiveness of the developed techniques and devices in comparison with traditional surgical treatment.
- 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.
- Scientific and technical effect: developed new techniques and devices for convergence and immobilization wound edges used for the treatment patients with SPD.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual surgery | Active comparator | Device: Usual Surgery |
| Hardware wound healing | Active comparator | Device: Hardware wound healing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Sacrococcygeal pilonidal sinus disease
- Must be able to transfer surgery
- Should not be allergic to antibiotics
Key exclusion criteria (3 listed)
- Low blood coagulation
- Вiseases, reducing immunity
- Insanity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hardware wound healing | Device | Hardware wound healing |
| Usual Surgery | Device | Usual surgery |
Primary outcome
primary wound closure
Time frame: up to 10-15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.